Clip applier and methods of use

ABSTRACT

A vessel closure device delivery system including a delivery device that couples to a vessel closure clip for delivering the clip onto a blood vessel and a retractable vessel locator is removeably attached to the delivery device, the distal end of the vessel locator being adapted to transition from a collapsed state suitable for insertion into a vessel and an expanded state that lodges against a wall of the vessel from inside the vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/791,846, filed Mar. 8, 2013, which is a continuation of U.S. patentapplication Ser. No. 13/039,087, filed Mar. 2, 2011, now U.S. Pat. No.8,398,656. U.S. patent application Ser. No. 13/039,087, filed Mar. 2,2011 is a continuation-in-part of U.S. patent application Ser. No.12/973,204, filed Dec. 20, 2010, now U.S. Pat. No. 8,202,294, which is adivisional of U.S. patent application Ser. No. 11/048,503, filed Feb. 1,2005, now U.S. Pat. No. 7,857,828, which is a continuation-in-part ofU.S. patent application Ser. No. 10/638,115, filed Aug. 8, 2003, nowU.S. Pat. No. 7,867,249, which is a continuation-in-part of U.S. patentapplication Ser. No. 10/356,214, filed Jan. 30, 2003, now U.S. Pat. No.7,905,900, each of which are incorporated herein by specific referencein its entirety. U.S. patent application Ser. No. 13/039,087, filed Mar.2, 2011 is also a continuation-in-part of U.S. patent application Ser.No. 11/852,190, filed on Sep. 7, 2007, now U.S. Pat. No. 8,758,398,which claims benefit of U.S. Provisional Application Ser. No.60/843,325, filed Sep. 8, 2006, each of which are incorporated herein byspecific reference in its entirety. U.S. patent application Ser. No.13/039,087, filed Mar. 2, 2011 is also a continuation-in-part of U.S.patent application Ser. No. 12/143,020, filed Jun. 20, 2008, now U.S.Pat. No. 8,202,293, which claims priority to U.S. ProvisionalApplication Ser. No. 60/946,030, filed Jun. 25, 2007 and U.S.Provisional Application Ser. No. 60/946,042, filed Jun. 25, 2007, and isa continuation-in-part of U.S. patent application Ser. No. 11/048,503,filed Feb. 1, 2005, now U.S. Pat. No. 7,857,828 which is acontinuation-in-part of U.S. patent application Ser. No. 10/638,115filed Aug. 8, 2003, now U.S. Pat. No. 7,867,249, which is acontinuation-in-part of U.S. patent application Ser. No. 10/356,214,filed Jan. 30, 2003, now U.S. Pat. No. 7,905,900, each of which areincorporated herein by specific reference in its entirety. U.S. patentapplication Ser. No. 13/039,087, filed Mar. 2, 2011 is also acontinuation-in-part of U.S. patent application Ser. No. 12/393,877,filed Feb. 26, 2009, now U.S. Pat. No. 8,905,937. U.S. patentapplication Ser. No. 13/039,087, filed Mar. 2, 2011 is also acontinuation-in-part of U.S. patent application Ser. No. 12/961,331,filed Dec. 6, 2010, now U.S. Pat. No. 8,821,534, each of which isincorporated herein by specific reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forclosing and/or sealing openings through tissue, and more particularly toapparatus and methods for delivering a closure element for closing apuncture in a blood vessel or other body lumen formed during adiagnostic or therapeutic procedure.

BACKGROUND

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and tissue into the vascular system. A guide wire may beadvanced through the needle and into the patient's blood vessel accessedby the needle. The needle then is removed, enabling an introducer sheathto be advanced over the guide wire into the vessel, e.g., in conjunctionwith or subsequent to a dilator. A catheter or other device may then beadvanced through a lumen of the introducer sheath and over the guidewire into a position for performing a medical procedure. Thus, theintroducer sheath may facilitate introducing various devices into thevessel, while minimizing trauma to the vessel wall and/or minimizingblood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath may beremoved, leaving a puncture site in the vessel wall. External pressuremay be applied to the puncture site until clotting and wound sealingoccur. This procedure, however, may be time consuming and expensive,requiring as much as an hour of a physician's or nurse's time. It isalso uncomfortable for the patient, and requires that the patient remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. Another technique has been suggested thatinvolves percutaneously suturing the puncture site, such as thatdisclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al.

To facilitate positioning devices that are percutaneously inserted intoa blood vessel, “bleed back” indicators have been suggested. Forexample, U.S. Pat. No. 5,676,974, issued to Kensey et al., discloses ableed back lumen intended to facilitate positioning of a biodegradableplug within a puncture site. This device, however, requires that ananchor of the plug be positioned within the vessel, and therefore, mayincrease the risk of over-advancement of the plug itself into thevessel.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al.,discloses a deployable loop that may be advanced through a sheath into avessel. The loop is intended to resiliently expand to engage the innerwall of the vessel, thereby facilitating holding the sheath in a desiredlocation with respect to the vessel. Accordingly, apparatus and methodsfor delivering a device for closing a vascular puncture site or otheropening through tissue would be useful.

BRIEF SUMMARY

The present invention is directed toward an apparatus and method fordelivering a closure element (e.g., clip) through tissue and into anopening formed in, or adjacent to, a wall of a blood vessel or otherbody lumen of any size.

Generally, an embodiment of such a clip applier apparatus can include acarrier tube carrying a closure element and a splitter configured tosplit the carrier tube. As such, the carrier tube can have an outersurface retaining the closure element in a substantially tubularconfiguration. Also, the carrier tube can be configured to split intoradially-expandable or outwardly bendable carrier flaps. The splittercan be disposed distally from the carrier tube, and can be configured tomove into a lumen of the carrier tube. Alternatively, the splitter canbe disposed in a distal end of the lumen of the carrier tube. Thesplitter can split the carrier tube into the radially-expandable oroutwardly bendable carrier flaps when moved through the lumen of thecarrier tube. Also, the splitter can have a proximal end with across-sectional profile smaller than a cross-sectional profile of adistal end.

In another embodiment, a clip applier apparatus for delivering a closureelement to an opening formed in a wall of a body lumen or body tissuecan include a slidable splitter or an expandable splitter. As such, thecarrier tube can have an outer surface retaining the closure element ina substantially tubular configuration. Also, the carrier tube can have alumen and slits at a distal end of the carrier tube. The carrier tubecan be configured to split at the slits so as to form outwardly bendablecarrier flaps. Additionally, the splitter can be disposed adjacent tothe slits so that the splitter can split the carrier tube at the distalend to form and outwardly bend the carrier flaps.

In one embodiment, the apparatus can include a splittable pusher tubethat splits similarly as the carrier tube. The pusher tube can beconfigured to split into radially-expandable or outwardly bendablepusher flaps by the splitter when moved distally with respect to thecarrier tube to deploy the closure element over the radially-expandableor outwardly bendable carrier flaps after expanding over the splitter.On the other hand, the expandable splitter can expand to split thepusher tube in order to form the pusher flaps.

In another embodiment, a clip applier apparatus for delivering a closureelement to an opening formed in a wall of a body lumen or body tissuecan include at least a partially splittable carrier tube and a splitter.Such a clip applier apparatus can include a partially splittable carriertube having a length and slits extending at least partially along thelength from a distal end toward a proximal end. The slits can beconfigured to separate at a distal portion of the carrier tube to formcarrier flaps. Also, the carrier tube can have an outer surfaceretaining a closure element in a substantially tubular configuration atthe splittable distal portion.

In one option, the splitter can be configured to move into a lumen ofthe carrier tube so as to split the distal portion of the carrier tubeinto the carrier flaps. The splitter can have a proximal end with across-sectional profile smaller than a cross-sectional profile of adistal end. Moreover, at least the distal end of the splitter can belarger than the lumen of the carrier tube.

In another option, the splitter can be an expandable splitter. As such,the entire splitter can selectively expand to split the carrier tubeinto the carrier flaps. Alternatively, the distal end of the splittercan selectively expand to split the carrier tube into the carrier flaps.

Additionally, the splitter can be coupled to a support tube so as toform a splitter tube. Alternatively, the splitter can be coupled to awire disposed within the lumen of the carrier tube. The wire can extendthrough a passage in the splitter and have an end with an expandeddiameter or retaining element disposed within a cavity in the splitterso that the end cannot pass through the passage.

A slidable splitter can be planar or volumetric, and can be shaped as atleast one of a cone, wedge, sphere, hemisphere, trapezoid, combinationsthereof, or other configurations that allow the splitter to perform thefunctions described herein. Also, the splitter can include a series ofcombinable splitters, wherein proximally disposed combinable splitterseach have a recess for receiving a proximal portion of adistally-adjacent combinable splitter. Similarly, the splitter caninclude at least a proximal combinable splitter and a distal combinablesplitter, wherein the proximal combinable splitter has a recess forreceiving a proximal end of the distal combinable splitter. Furthermore,the splitter can be adapted to take hold of or grab a portion of tissueto the splitter. To aid with this functionality, the splitter caninclude teeth, barbs, or other structures that enable tissue to beselectively secured to a portion of the splitter.

In one embodiment, the present invention can use a clip applier having acarrier tube and a splitter in a method for closing an opening formed ina wall of a body lumen or body tissue. Such a method can include thefollowing: positioning a carrier tube adjacent to the opening, thecarrier tube having a distal end with an outer surface retaining aclosure element in a substantially tubular configuration, the carriertube having a lumen and being configured to split into flaps; splittinga distal end of the carrier tube with a splitter so as to form the flapsthat deform outwardly over the splitter; and deploying the closureelement from the outwardly deformed flaps of the carrier tube and overthe splitter so that the closure element engages at least a portion ofthe wall of the body lumen or the body tissue whereby the opening isdrawn substantially closed.

Accordingly, the carrier tube can be split with the splitter by at leastone of the following: moving the splitter proximally with respect to thecarrier tube; moving the carrier tube distally with respect to thesplitter, or simultaneously moving the splitter proximally with respectto the carrier tube and moving the carrier tube distally with respect tothe splitter; expanding the splitter; or selectively expanding a distalportion of the splitter.

In one embodiment, a tissue-grabbing splitter can be used in a methodfor closing an opening formed in a wall of a body lumen or body tissue.Such a method can include grabbing tissue around the opening with teethand/or barbs on the splitter, and drawing the grabbed tissue toward theopening when the splitter is being pulled therethrough.

The present invention is also directed toward an apparatus and methodfor delivering a closure element through tissue and into an openingformed in, or adjacent to, a wall of a blood vessel or other body lumenof any size. It is further contemplated that the closure element anddevices described herein can be utilized for other medical proceduresnot described herein, and it shall be further understood that themethods described herein should be considered exemplary and notlimiting.

Generally, an embodiment of a closure element in accordance with thepresent can include a clip for closing an opening formed in a wall of abody lumen or body tissue. Such a clip can include a shape-memory cliphaving a relaxed configuration with a substantially planar-annular bodydefining a lumen with a plurality of tines directed inwardly from thebody. Additionally, the clip can be oriented and held by a clip applierin a retaining configuration having a substantiallyasymmetrically-elongated tubular shape with a substantially trapezoidallongitudinal cross-sectional profile and a body portion having theplurality of tines being longitudinally and distally directed with afirst tine of the plurality being more distally oriented compared to asubstantially opposite second tine being more proximal. Also, the clipcan be capable of retracting to a deploying configuration having asubstantially symmetrical tubular shape with a substantially rectangularlongitudinal cross-sectional profile with the first tine beingsubstantially even with the second tine when the clip is being deliveredfrom the clip applier to close the opening.

Additionally, the clip in the retaining configuration can have a lumenthat has a smaller orthogonal cross-sectional profile (e.g., orthogonalto longitudinal direction) compared to the lumen in the deployingconfiguration. Alternatively, the clip in the retaining configurationcan have a lumen that has a more oval orthogonal cross-sectional profilecompared to the lumen in the deploying configuration having a morecircular orthogonal cross-sectional profile. Also, the clip canautomatically retract from the retaining configuration to the deployingconfiguration when being released from the clip applier. Further, theclip can automatically convert to the relaxed configuration from thedeploying configuration after being released from the clip applier.

In another embodiment, the present invention can include a clip applierapparatus for delivering a clip to an opening formed in a wall of a bodylumen or body tissue. Such a clip applier can include a shape-memoryclip as described herein. Additionally, the clip applier can include acarrier tube having an outer surface configured for slidably retainingthe clip in a retaining configuration and slidably delivering the clipin a deploying configuration, wherein the retaining configuration anddeploying configuration are described herein.

In one embodiment, the clip applier can include a pusher tube that canpush the clip from the retaining configuration to the deployingconfiguration. Also, the pusher tube can be configured to distally pushthe clip in the retaining configuration over the carrier tube toward adistal end of the carrier tube. Further, the pusher tube can beconfigured to distally push the clip over a distal end of the carriertube so that the clip retracts from the retaining configuration to thedeploying configuration.

Additionally, the carrier tube can be configured so that the outersurface corresponds in shape and size with the lumen of the clip in theretaining configuration. Accordingly, the outer surface of the carriertube can be generally oval in shape. Also, the outer surface can have asmaller orthogonal cross-sectional profile compared to the size of thelumen of the clip in the deploying configuration.

In yet another embodiment, the clip applier can include a clip expanderthat is capable of expanding the clip during deployment. As such, theclip expander can be a selectively expandable shape-memory clipexpander. Also, the clip expander can be disposed at a distal portion ofthe carrier tube.

In still another embodiment, the clip applier can include a cover tubethat contains any of the carrier tube, pusher tube, clip, and/or clipexpander. As such, the cover tube can define a lumen that retains theclip in the retaining configuration. Also, the lumen of the cover tubecan retain the clip expander in a contracted orientation so that theclip expander can be capable of expanding when moved distally past adistal end of the cover tube.

Another embodiment of the present invention can include a method forclosing an opening formed in a wall of a body lumen or body tissue. Sucha method can include positioning a carrier tube adjacent to the opening,wherein the carrier tube has a distal portion with an outer surfaceretaining a shape-memory clip in a retaining configuration. The carriertube, clip, and retaining configuration can be as described herein.Additionally, the method can include pushing the clip over a distal endof the carrier tube so that the clip retracts to a deployingconfiguration, wherein the deploying configuration is described herein.Further, the method can include ejecting the clip from the carrier tubeso that at least a portion of the plurality of tines disposed on thebody portion of the clip engages a portion of the wall of the body lumenor the body tissue whereby the opening is drawn substantially closed.

Additionally, the method can include pushing the clip toward the distalend of the carrier tube with a pusher tube being configured to distallypush the clip in the retaining configuration. Also, the method caninclude flattening the clip, after being deployed from the carrier tube,to a relaxed configuration with a substantially planar-annular bodydefining a lumen with a plurality of tines directed inwardly from thebody of the clip, wherein at least a portion of the tines have inwardlydrawn a portion of the wall of the body lumen or the body tissue so asto substantially close the opening. Further, the method can includeexpanding the clip from the retaining configuration having a lumen witha smaller orthogonal cross-sectional profile to the deployingconfiguration so that the lumen has a larger orthogonal cross-sectionalprofile. Optionally, the clip can be expanded by a selectivelyexpandable shape-memory clip expander. Furthermore, the method caninclude expanding the clip from the retaining configuration having alumen with a more oval orthogonal cross-sectional profile to thedeploying configuration so that the lumen has a more circular orthogonalcross-sectional profile.

An embodiment of an apparatus for locating a surface of a body lumen isdisclosed. The apparatus includes a locator assembly that has a distalend region configured to extend into an opening of the body lumen and toselectably engage at least a portion of the body lumen adjacent to theopening. The distal end region includes at least one surface engagingelement that is configured to engage the surface of the body lumen. Theapparatus includes a measuring device that is in electricalcommunication with the surface engaging element. The measuring device isconfigured to determine changes in measurable characteristics of thesurface engaging element.

An embodiment of a method for locating a surface of a body lumen isdisclosed. The method includes inserting a locator assembly through anopening of the body lumen. The locator assembly includes a distal endregion having a surface engaging element configured to selectivelyengage the surface of the body lumen. The locator assembly is positionedin close proximity to the opening of the body lumen. A measurablecharacteristic of the surface engaging element is measured within thebody lumen. It is determined whether the measurable characteristic ofthe surface engaging element indicates that the surface engaging elementhas engaged the surface of the body lumen.

An embodiment of a surface engaging element is disclosed. The surfaceengaging element includes a proximal end portion that has at least oneretaining portion. The surface engaging element includes a distal endportion that has at least one retaining portion. The surface engagingelement includes at least one engaging member that extends toward theproximal end portion and extends toward the distal end portion. The atleast one engaging member is configured to engage a surface of a bodylumen.

In one embodiment, the present invention includes an apparatus forpositioning a closure element to close an opening in a body lumen. Suchan apparatus includes a carrier assembly and a distal tissue engagingdevice. The carrier assembly is configured to support a closure elementin a substantially tubular configuration in a first diameter. Theclosure element is configured to substantially uniformly deform from asubstantially tubular configuration to a natural, substantially planarconfiguration. The distal tissue engaging device is selectably axiallydisplaceable relative to at least a portion of the carrier assembly. Assuch, the distal tissue engaging device moves between a tissue engagingcondition and a tissue closing condition. The tissue engaging conditionengages opposing portions of an arterial wall defining said body lumenadjacent to the opening. The tissue closing condition urges the engagedopposing portions of the arterial wall substantially together such thatthe closure element may be deployed from the delivery assembly to engagethe opposed portions of the arterial wall and to return to the natural,substantially planar configuration.

In one embodiment, the distal tissue engaging device includes two ormore opposed engaging tongs having respective end tips configured toopen radially in directions extending beyond the first diameter toinitially engage the opposing portions of the arterial wall, in theengaging condition.

In one embodiment, the carrier assembly further includes a cover memberprotecting at least the closure element which is contained therein.

In one embodiment, the distal tissue engaging device is integral with adistal end of the cover member.

In one embodiment, the carrier assembly is formed and dimensioned forsliding axial, reciprocating, receipt in a lumen of an introducer sheathextending through said tissue and terminating proximate the opening. Thetissue engaging device is configured to cooperate with the introducersheath to enable movement between the engaging condition and the closingcondition.

In one embodiment, the present invention includes an apparatus fordelivering and deploying a substantially resilient closure elementthrough tissue to an opening in a body lumen perimeterically defined byopposing arterial walls. The closure element is configured tosubstantially uniformly deform from a natural, substantially resilientplanar configuration to a substantially tubular configuration having asubstantially natural transverse cross-sectional dimension. Theapparatus includes a delivery assembly positionable through the tissuetoward the opening in the body lumen. Also, the delivery assembly has adistal tissue engaging device and a carrier assembly configured tosupport the closure element in the substantially tubular configurationin a first diameter. The distal tissue engaging device is selectablyaxially displaceable relative to at least a portion of the carrierassembly between a tissue engaging condition and a tissue closingcondition. The tissue engaging condition engages the opposing arterialwalls of the body lumen adjacent to the opening. The tissue closingcondition urges the engaged opposing arterial walls substantiallytransversely together such that the closure element may be deployed fromthe delivery assembly, while substantially maintained in the firstdiameter, into the opposing arterial walls. The closure element isoriented to engage the engaged opposing arterial walls when deployed andto return to the natural, substantially planar configuration and thenatural, transverse cross-sectional dimension such that the engagedopposing arterial walls are drawn substantially closed.

In one embodiment, the apparatus includes a locator configured toposition the carrier assembly and distal tissue engaging device adjacentto the opening in the body lumen. Also, the locator has a distal locatorportion selectably controllable between an unexpanded state and anexpanded state for engaging the opposing portions of the arterial wallof the body lumen.

In one embodiment, the apparatus includes a distal tissue locatorportion contained on the delivery assembly. The distal tissue locatorportion is configured to facilitate detection of the body lumen andincludes one or more expansion elements configured to expandsubstantially transversely with respect to a longitudinal axis of thedistal locator portion.

In one embodiment, the distal locator portion is selectably controllablebetween an unexpanded state and an expanded state for engaging saidopposing arterial walls of said body lumen.

In one embodiment, while in the unexpanded state, the distal locatorportion has a transverse cross-sectional dimension less than that of theopening. Also, while in the expanded state, the distal locator portionhas a transverse cross-sectional dimension greater than or substantiallyequal to that of said opening.

In one embodiment, the present invention includes an apparatus forpositioning a closure element to close an opening in a body lumen. Suchan apparatus includes a carrier assembly and a distal tissue engagingdevice. The carrier assembly has a tubular body configured to receive aclosure element in a substantially tubular configuration in a firstdiameter prior to deployment. Also, the tubular body has a distal port.The distal tissue engaging device is disposed within the tubular bodyand is selectably axially displaceable from the distal port. A portionof the distal tissue engaging device is biased to selectively radiallyextend outwardly from a longitudinal axis of the tubular body tointravascularly engage opposing arterial walls of the body lumen. Aportion of the distal tissue engaging device urges the engaged opposingportions of the arterial wall substantially together as the distaltissue engaging device moves proximally. The closure element is thendeployed to engage the opposed portions of the arterial wall.

In one embodiment, the carrier assembly includes a cover member defininga lumen configured for slidable receipt of the closure element therein.

In one embodiment, the carrier assembly includes a pusher member thatslides for distally deploying the closure element.

In one embodiment, the pusher member and the tubular body are disposedas a nested, telescoping tube set with a common longitudinal axis.

In one embodiment, the tubular body includes a tissue locator portion.The tissue locator portion includes a bleed back shaft having a bleedback port distally disposed on a distal end of the tubular body.

In one embodiment, the present invention includes a closure system forclosing an opening formed in a body lumen perimeterically defined byopposing arterial walls. Such a closure system includes a closureelement, a delivery assembly, and a pusher member. The closure elementis adapted to deform from a natural, substantially resilient planarconfiguration to a substantially tubular configuration that has asubstantially natural transverse cross-sectional dimension. The deliveryassembly is capable of being positioned through the tissue and into theopening in the body lumen.

Additionally, the delivery assembly has an elongated body, a carrierassembly and a distal tissue engaging device. The carrier assemblyincludes a carrier seat configured to carry and peripherally support theclosure element in the substantially tubular configuration in a firstdiameter. The distal tissue engaging device is selectably, axiallydisplaceable relative to the carrier seat between an engaging conditionand a closing condition. The engaging condition engages the opposingarterial walls of the body lumen adjacent to the opening. The closingcondition urges the engaged opposing arterial walls substantiallytransversely together such that the closure element may be deployed fromthe carrier assembly, while substantially maintained in the firstdiameter, into the opposing arterial walls.

The pusher member is slidably disposed about the elongated body forrelative axial sliding displacement therebetween. The pusher member hasa contact portion disposed proximally adjacent to the closure element inorder to selectively distally deploy the closure element from thecarrier assembly. The closure element is deployed in the substantiallytubular configuration so as to engage the opposing arterial walls and toreturn to the natural, substantially planar configuration and thenatural, transverse cross-sectional dimension such that the engagedopposing arterial walls are drawn substantially closed.

In one embodiment, the delivery assembly includes a tubular bodysupporting the carrier seat. Also, the tubular body defines a centralreceiving lumen extending longitudinally therethrough that is configuredfor sliding support of the tissue engaging device for axial movementbetween the engaging condition and the closing condition.

In one embodiment, the pusher member comprises one or more distallyextending longitudinal extensions.

In one embodiment, the closure system includes a locator slidablyreceivable within the pusher member and the delivery assembly.

In one embodiment, the present invention includes a method for closingan opening defined by edges of arterial walls of a body lumen. Such amethod includes the following: positioning a distal end region of acarrier assembly through tissue adjacent to an opening so that a distaltissue engaging device engages opposing portions of arterial walls, thedistal end region of the carrier assembly includes a carrier seatconfigured to seat said closure element thereon in a substantiallytubular configuration, having a first diameter; urging the engagedarterial walls radially inwardly and toward one another such that atleast opposed edges of the arterial walls are drawn with the firstdiameter of the closure element; and distally deploying the closureelement from the carrier assembly without further substantial radialexpansion for the closure element, in the substantially tubularconfiguration, such that the closure element engages the arterial walls,and returns to the natural, planar configuration and the naturalcross-section wherein the tissue is drawn substantially closed.

In one embodiment, the engagement of the arterial walls is performed byextravascularly engaging the arterial walls with the tissue engagingdevice.

In one embodiment, the engagement of the arterial walls is performed byintravascularly engaging the arterial walls with the tissue engagingdevice.

In one embodiment, the method includes placing a distal end region of alocator portion through tissue into the opening.

In one embodiment, the method includes engaging the arterial wallsadjacent to the opening.

In one embodiment, the method includes orientating the carrier assemblyproximal to the locator portion.

In one embodiment, the present invention is a medical device fordelivering a closure element to an opening formed in a body lumen orbody tissue with improved hemostasis. Such a medical device can includea locator assembly, a hemostasis assembly, and a carrier assembly. Thelocator assembly can have a distal end region configured to extendthrough tissue into the opening and to selectively engage an internalsurface of said body lumen adjacent to the opening so as to provide adesired position of the medical device relative to the body lumen. Thedistal end region can include a locator that is implantable to improvehemostasis. Also, the locator can be a hemostatic locator with similarhemostatic characteristics as the hemostasis assembly. The hemostasisassembly can be associated with the locator assembly, whether or not thelocator assembly includes an implantable locator or hemostatic locator.The hemostasis assembly can have a selectively expandable member on adistal end configured to extend into the opening so as to be disposedtherein when the locator assembly is in contact with said internalsurface of said body lumen. The expandable member can be configured toexpand laterally when disposed in the opening so as to substantiallyplug the opening to provide hemostasis. Also, the hemostasis assemblycan include a member, such as the selectively expandable member or otheraspect of the distal end that includes a hemostatic agent coatedthereon. The carrier assembly can be slidably coupled with the locatorassembly and hemostasis assembly. The carrier assembly can have acarrier member supporting the closure element and a cover memberretaining the closure element within the carrier assembly. The carrierassembly can be positioned through the tissue adjacent to the openingand can be configured to distally deploy the closure element such thatthe closure element substantially uniformly expands to a cross-sectionthat is greater than a natural cross-section of the closure element. Theclosure element can be configured to engage the body lumen when deployedsuch that the lumen is drawn substantially closed.

In one embodiment, the expandable member of the hemostasis assembly canbe selectively controlled between an unexpanded state and an expandedstate for engaging a wall of said opening. The expandable member of thehemostasis assembly in the unexpanded state can have a cross-sectionthat is less than a cross-section of the opening. The expandable memberof the hemostasis assembly in the expanded state can have across-section that is greater than or substantially equal to across-section of the opening. Also, a hemostatic agent can be includedwith the expandable member or the expandable member can be configured torelease some hemostatic agent when expanding or fully expanded.

In one embodiment, the expandable member of the hemostasis assembly caninclude one or more expansion elements configured to expandsubstantially transversely with respect to a longitudinal axis of thehemostasis assembly. The one or more expansion elements can be disposedwithin a flexible portion of the expandable member of the hemostasisassembly so that the expansion elements flex the flexible portion fromthe unexpanded state to the expanded state in order to plug the openingand provide hemostasis.

In one embodiment, the expandable member includes a substantiallyflexible and/or deformable member with a substantially fixed end regionfixedly coupled with the hemostasis assembly, an intermediate region,and a movable end region movable coupled with the hemostasis assemblysuch that the intermediate region is configured to expand transverselyoutwardly when the movable end region is axially moved toward thesubstantially fixed end region.

In one embodiment, the hemostasis assembly can include a control systemcoupled to a proximal end region of the hemostasis assembly. The controlsystem can be configured to selectively control the expandable member ofthe hemostasis assembly between the expanded state and the unexpandedstate. The control system can expand the expandable member and maintainthe expandable member in the expanded state for a desired duration whenthe control system is engaged. The control system can change theexpandable member from the expanded state to the unexpanded state whenthe control system is disengaged.

In one embodiment, the expandable member can include an expandablebladder. The bladder can be coupled to a fluid source that can inflatethe bladder. For example, an inflation tube can be coupled with thebladder such that fluid, such as air, can be passed through theinflation tube to expand the bladder. A pump or other device that cancause the bladder to inflate may also be associated with the bladder andinflation tube.

In one embodiment, the expandable member expands by longitudinallycompressing the expandable member so as to laterally expand theexpandable member.

In one embodiment, the hemostasis assembly can include an actuatormember that is actuated so as to expand the expandable member.

In one embodiment, the present invention includes a medical system forclosing an opening formed in a body lumen or body tissue with improvedhemostasis. Such a system can include an introducer sheath, locatorassembly, hemostasis assembly, closure element, and carrier assembly forthe closure element. The introducer sheath can be configured to bedeployed into the body lumen or body tissue. The introducer sheath caninclude a proximal end, a distal end, and a lumen extending from theproximal end to the distal end. The locator assembly can be configuredso as to be capable of being disposed in the lumen of the introducersheath. The locator assembly can have a locator member at a distal endregion of the locator assembly configured to extend through tissue intothe opening and to selectively engage an internal surface of the bodylumen adjacent to the opening so as to provide a desired position of themedical device relative to the opening and body lumen. Optionally, thelocator member can be implantable and either biostable or biodegradable.In another option, the locator member can be hemostatic. The hemostasisassembly can be associated with the locator assembly, and can be capableof being disposed in the lumen of the introducer sheath with the locatorassembly. The hemostasis assembly can have a selectively expandablemember on a distal end configured to extend into the opening so as to bedisposed therein when the locator assembly is in contact with theinternal surface of the body lumen. The expandable member can beconfigured to expand laterally when disposed in the opening so as tocontact the wall of the opening and substantially plug the opening toprovide hemostasis. The carrier assembly can be slidably coupled withthe locator assembly and hemostasis assembly, and can be dimensioned soas to be capable of being disposed in the introducer sheath with thelocator assembly and the hemostasis assembly. The carrier assembly canhave a carrier member supporting the closure element and a cover memberretaining the closure element within the carrier assembly. The carrierassembly can be positioned through the tissue adjacent to the opening,and can be configured to distally deploy the closure element such thatthe closure element substantially uniformly expands to a cross-sectionthat is greater than a natural cross-section of the closure element. Theclosure element can be configured to engage the tissue when deployedsuch that the tissue is drawn substantially closed.

In one embodiment, the expandable member of the hemostasis assembly canbe selectively controlled between an unexpanded state and an expandedstate for engaging a wall of the opening. Also, the locator member ofthe locator assembly can be selectively controlled between an unexpandedstate and an expanded state for engaging the body lumen. The expandablemember of the hemostasis assembly and the locator member of the locatorassembly both can be in the unexpanded state and can have across-section that is less than a cross-section of the opening. Theexpandable member of the hemostasis assembly and the locator member ofthe locator assembly both in the expanded state can each have across-section that is greater than or substantially equal to across-section of the opening. Optionally, the expandable member andlocator member can be configured to cooperate in providing hemostasis.This can allow for the locator member to apply pressure to the insidewall of a blood vessel while the expandable member of the hemostasisassembly can apply pressure to the outside of the vessel and/or againstthe vessel walls surrounding the opening in the vessel.

In one embodiment, the expandable member of the hemostasis assembly caninclude one or more hemostasis expansion elements configured to expandsubstantially transversely with respect to a longitudinal axis of thehemostasis assembly. The locator member of the locator assembly can alsoinclude one or more locator expansion elements configured to expandsubstantially transversely with respect to a longitudinal axis of thelocator assembly.

In one embodiment, the hemostasis expansion elements are disposed withina flexible portion of the expandable member of the hemostasis assemblyso that the one or more hemostasis expansion elements flex the flexibleportion from the unexpanded state to the expanded state in order to plugthe opening and provide hemostasis. The locator expansion elements canbe substantially equally distributed about an outer periphery of thelocator member of the locator assembly.

In one embodiment, each of the locator expansion elements can include asubstantially flexible member with a substantially fixed end regionfixedly coupled with said distal end region of the locator assembly, anintermediate region, and a movable end region movable coupled with thedistal end region of the locator assembly such that the intermediateregions are configured to expand transversely outwardly when the movableend regions are axially moved toward said substantially fixed endregions.

In one embodiment, the expandable member of the hemostasis assembly caninclude a substantially flexible member with a substantially fixed endregion fixedly coupled with the hemostasis assembly, an intermediateregion, and a movable end region movable coupled with the hemostasisassembly such that the intermediate region is configured to expandtransversely outwardly when the movable end region is axially movedtoward the substantially fixed end region.

In one embodiment, the hemostasis assembly can include a hemostasiscontrol system coupled to a proximal end region of the hemostasisassembly. The hemostasis control system can be configured to selectivelycontrol the expandable member of the hemostasis assembly between theexpanded state and the unexpanded state.

In one embodiment, the locator assembly can include a locator controlsystem coupled to a proximal end region of the locator assembly. Thelocator control system can be configured to selectively control thelocator member of the locator assembly between the expanded state andthe unexpanded state. The locator control can also be configured torelease the locator upon application of the closure element so that thelocator is retained against the inner wall of the vessel in order tofacilitate hemostasis. The hemostasis control system and locator controlsystem can be integrated. Also, the hemostasis control system andlocator control system can be included in the same control system.

Generally, an embodiment of a closure element in accordance with thepresent can include a clip for closing an opening formed in a wall of abody lumen or body tissue. Such a clip can include a shape-memory cliphaving a relaxed configuration with a substantially planar-annular bodydefining a lumen with a plurality of tines directed inwardly from thebody. Additionally, the clip can be oriented and held by a clip applierin a retaining configuration having a substantiallyasymmetrically-elongated tubular shape with a substantially trapezoidallongitudinal cross-sectional profile and a proximal portion having theplurality of tines being longitudinally and distally directed with afirst tine of the plurality being more distally oriented compared to asubstantially opposite second tine being more proximal. Also, the clipcan be capable of retracting to a deploying configuration having asubstantially symmetrical tubular shape with a substantially rectangularlongitudinal cross-sectional profile with the first tine beingsubstantially even with the second tine when the clip is being deliveredfrom the clip applier to close the opening.

Additionally, the clip in the retaining configuration can have a lumenthat has a smaller orthogonal cross-sectional profile (e.g., orthogonalto longitudinal direction) compared to the lumen in the deployingconfiguration. Alternatively, the clip in the retaining configurationcan have a lumen that has a more oval orthogonal cross-sectional profilecompared to the lumen in the deploying configuration having a morecircular orthogonal cross-sectional profile. Also, the clip canautomatically retract from the retaining configuration to the deployingconfiguration when being released from the clip applier. Further, theclip can automatically convert to the relaxed configuration from thedeploying configuration after being released from the clip applier. Suchconversion to the relaxed configuration can allow for the tines of theclip to grab the locator during the relaxation process, and retain thelocator against the blood vessel wall to facilitate hemostasis.

In another embodiment, the present invention can include a clip applierapparatus for delivering a clip to an opening formed in a wall of a bodylumen or body tissue. Such a clip applier can include a shape-memoryclip as described herein. Additionally, the clip applier can include acarrier tube having an outer surface configured for slidably retainingthe clip in a retaining configuration and slidably delivering the clipin a deploying configuration, wherein the retaining configuration anddeploying configuration are described herein.

In one embodiment, the clip applier can include a pusher tube that canpush the clip from the retaining configuration to the deployingconfiguration. Also, the pusher tube can be configured to distally pushthe clip in the retaining configuration over the carrier tube toward adistal end of the carrier tube. Further, the pusher tube can beconfigured to distally push the clip over a distal end of the carriertube so that the clip retracts from the retaining configuration to thedeploying configuration.

Additionally, the carrier tube can be configured so that the outersurface corresponds in shape and size with the lumen of the clip in theretaining configuration. Accordingly, the outer surface of the carriertube can be generally oval in shape. Also, the outer surface can have asmaller orthogonal cross-sectional profile compared to the size of thelumen of the clip in the deploying configuration.

In yet another embodiment, the clip applier can include a clip expanderthat is capable of expanding the clip during deployment. As such, theclip expander can be a selectively expandable shape-memory clipexpander. Also, the clip expander can be disposed at a distal portion ofthe carrier tube.

In still another embodiment, the clip applier can include a cover tubethat contains any of the carrier tube, pusher tube, clip, and/or clipexpander. As such, the cover tube can define a lumen that retains theclip in the retaining configuration. Also, the lumen of the cover tubecan retain the clip expander in a contracted orientation so that theclip expander can be capable of expanding when moved distally past adistal end of the cover tube.

Another embodiment of the present invention can include a method forclosing an opening formed in a wall of a body lumen or body tissue. Sucha method can include positioning a carrier tube adjacent to the opening,wherein the carrier tube has a distal portion with an outer surfaceretaining a shape-memory clip in a retaining configuration. The carriertube, clip, and retaining configuration can be as described herein.Additionally, the method can include pushing the clip over a distal endof the carrier tube so that the clip retracts to a deployingconfiguration, wherein the deploying configuration is described herein.Further, the method can include ejecting the clip from the carrier tubeso that at least a portion of the plurality of tines disposed on theproximal end of the clip engages a portion of the wall of the body lumenor the body tissue whereby the opening is drawn substantially closed.

Additionally, the method can include pushing the clip toward the distalend of the carrier tube with a pusher tube being configured to distallypush the clip in the retaining configuration. Also, the method caninclude flattening the clip, after being deployed from the carrier tube,to a relaxed configuration with a substantially planar-annular bodydefining a lumen with a plurality of tines directed inwardly from thebody of the clip, wherein at least a portion of the tines have inwardlydrawn a portion of the wall of the body lumen or the body tissue so asto substantially close the opening. Further, the method can includeexpanding the clip from the retaining configuration having a lumen witha smaller orthogonal cross-sectional profile to the deployingconfiguration so that the lumen has a larger orthogonal cross-sectionalprofile. Optionally, the clip can be expanded by a selectivelyexpandable shape-memory clip expander. Furthermore, the method caninclude expanding the clip from the retaining configuration having alumen with a more oval orthogonal cross-sectional profile to thedeploying configuration so that the lumen has a more circular orthogonalcross-sectional profile.

In one embodiment, a method of closing an opening in a body lumen of asubject can include use of a medical device having a locator assemblyand hemostasis assembly as described herein. Such a method can include:locating the body lumen with the locator; expanding the expandablehemostasis member so as to provide hemostasis to the opening; anddeploying the closure element into the body lumen so as to close thebody lumen. The method can also include expanding the locator from anunexpanded state to an expanded state and pulling the locator againstthe internal surface of the body lumen. The locator can be configured toautomatically expand when moved out from the tube of the locatorassembly.

In one embodiment, the locator is configured to be implanted. As such,deployment of the closure element traps the implantable locator againstand adjacent to the internal surface of the body lumen. Optionally, thelocator assembly includes a suture coupled to the implantable locator,and the suture is cut after the opening of the body lumen is closed. Thesuture can be biodegradable and any portion of the suture remaining inthe subject degrades. The locator can be biostable or biodegradable.

In one embodiment, the locator is configured to be withdrawn from thebody lumen as the closure element is deployed to close the opening. Thelocator assembly can include at least a first wire and a second wirethat are coupled to the locator such that pulling on both the first wireand second wire draws the locator against the internal surface of thebody lumen, and pulling on one of the first wire or second wire unwindsthe locator and withdraws the locator from the body lumen.

In one embodiment, a hemostasis assembly can have a hemostasis tube, andan expandable hemostasis member located at a distal end of thehemostasis tube, said expandable hemostasis member being configured toselectively expand at an opening in a body lumen so as to cover or plugthe opening and provide hemostasis.

In one embodiment, an implantable body lumen locator can include: abiocompatible locator configured to be in an unexpanded state whilebeing inserted through an opening in a body lumen and to be in anexpanded state that is larger in diameter than the opening; and alocator assembly configured to deliver the biocompatible locator intothe body lumen and selectively expand the locator assembly, andconfigured to release the biocompatible locator therefrom forimplantation. The locator assembly can include one or more suturescoupled to the locator, the one or more sutures being configured to becut.

In one embodiment, an implantable body lumen locator can include: abiocompatible locator configured to be in an unexpanded state whilebeing inserted through an opening in a body lumen and to be in anexpanded state that is larger in diameter than the opening; and alocator assembly configured to deliver the biocompatible locator intothe body lumen and selectively expand the locator assembly, andconfigured to retract the biocompatible locator from the body lumen,said locator assembly having at least a first locator wire coupled witha first end of the locator and a second locator wire coupled to a secondend of the locator such that pulling on both the first locator wire andsecond locator wire draws the locator against the internal surface ofthe body lumen, and pulling on one of the first wire or second wireunwinds the locator and withdraws the locator from the body lumen.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features ofembodiments of the present invention, a more particular description ofembodiments of the present invention will be rendered by reference tothe appended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. The invention will be described andexplained with additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 provides a general illustration of an apparatus for closingopenings formed in blood vessel walls in accordance with the presentinvention.

FIG. 2A illustrates one embodiment of a locator assembly for theapparatus of FIG. 1.

FIG. 2B illustrates one embodiment of a distal end region of the locatorassembly of FIG. 2A when the distal end region is in an unexpandedstate.

FIG. 2C illustrates the distal end region of the locator assembly ofFIG. 2B when the distal end region is in an expanded state.

FIGS. 2B′ and 2C′ illustrate an alternative embodiment of a locatorassembly for locating a surface of a body lumen, in accordance with thepresent invention.

FIGS. 2B″ and 2C″ illustrate a further embodiment of a locator assemblyfor locating a surface of a body lumen, in accordance with the presentinvention.

FIGS. 2B′″ and 2C′″ illustrate a still further embodiment of a locatorassembly for locating a surface of a body lumen, in accordance with thepresent invention.

FIG. 2D illustrates one embodiment of a proximal end region of thelocator assembly of FIG. 2A.

FIG. 3A illustrates one embodiment of a carrier assembly for theapparatus of FIG. 1.

FIG. 3B illustrates one embodiment of a carrier member for the carrierassembly of FIG. 3A.

FIG. 3C illustrates one embodiment of a pusher member for the carrierassembly of FIG. 3A.

FIG. 3D illustrates one embodiment of a cover member for the carrierassembly of FIG. 3A.

FIG. 3E illustrates one embodiment of a support member for the carrierassembly of FIG. 3A.

FIG. 4A illustrates a cross-sectional side view of one embodiment of atriggering system for the carrier assembly of FIG. 3A.

FIG. 4B illustrates a first detailed cross-sectional side view of thetriggering system of FIG. 4A.

FIG. 4C illustrates a detailed view of the triggering system of FIG. 4B.

FIG. 4D illustrates a second detailed cross-sectional side view of thetriggering system of FIG. 4A.

FIG. 5A illustrates the carrier control system of FIGS. 4A-D as thecarrier assembly of FIG. 3A moves distally from an initial predeterminedposition.

FIG. 5B illustrates the carrier control system of FIGS. 4A-D as thecarrier assembly of FIG. 3A reaches a first predetermined position.

FIG. 5C illustrates the carrier control system of FIGS. 4A-D as thecarrier assembly of FIG. 3A reaches a second predetermined position.

FIG. 6A illustrates a top view of one embodiment of a closure element ina natural, planar configuration and with a natural cross-section for usewith the apparatus of FIG. 1.

FIG. 6B illustrates a side view of the closure element of FIG. 6A.

FIG. 6C illustrates a top view of the closure element of FIGS. 6A-Bafter a natural cross-section of the closure element has been reduced.

FIG. 6D illustrates a side view of the reduced closure element of FIG.6C.

FIG. 6E illustrates a side view of the reduced closure element of FIGS.6C-D as the reduced closure element transitions from the natural, planarconfiguration to a tubular configuration.

FIG. 6F illustrates a top view of the closure element of FIGS. 6C-D uponcompleting the transition from the natural, planar configuration to asubstantially tubular configuration.

FIG. 6G illustrates a side view of the closure element of FIG. 6F.

FIG. 7A illustrates the closure element of FIGS. 6A-G prior to beingdisposed upon the carrier member of FIG. 3B.

FIG. 7B illustrates the closure element of FIGS. 6A-G upon beingdisposed upon the carrier member of FIG. 3B.

FIG. 7C illustrates the closure element of FIGS. 6A-G as the covermember of FIG. 3D receives the carrier member of FIG. 3B.

FIG. 7D illustrates the closure element of FIGS. 6A-G being retainedsubstantially within the carrier assembly of FIG. 3A when the carriermember of FIG. 3B is disposed substantially within the cover member ofFIG. 3D.

FIG. 8A illustrates a sheath that is positioned through tissue and intoan opening formed in a wall of a blood vessel.

FIG. 8B illustrates the apparatus of FIG. 1 as prepared to be receivedby the sheath of FIG. 8A.

FIG. 8C illustrates a locator assembly of the apparatus of FIG. 8B beingadvanced distally into the blood vessel.

FIG. 8D illustrates a distal end region of the locator assembly of FIG.8C extending into the blood vessel and being transitioned into anexpanded state.

FIG. 8E illustrates the distal end region of FIG. 8D being retractedproximally to engage an inner surface of the blood vessel wall.

FIG. 8F illustrates a carrier assembly of the apparatus of FIG. 8B beingadvanced distally into the sheath of FIG. 8A once the distal end regionof FIG. 8D has engaged the inner surface of the blood vessel wall.

FIG. 8G illustrates relative positions of a tube set of the carrierassembly of FIG. 5F upon reaching a first predetermined position.

FIG. 8H illustrates the relative positions of the tube set of FIG. 8Gupon reaching a second predetermined position.

FIG. 8I illustrates a position of a pusher member of the tube set ofFIG. 8H moving distally from the second predetermined position andbeginning to distally deploy a closure element.

FIG. 8J illustrates the closure element of FIG. 8I upon being deployedand engaging tissue adjacent to the opening in the blood vessel wall.

FIG. 8K illustrates the closure element of FIG. 8J transitioning fromthe substantially tubular configuration to the natural, planarconfiguration while engaging the engaged tissue.

FIG. 8L illustrates the closure element of FIG. 8K drawing the engagedtissue substantially closed and/or sealed.

FIG. 9 illustrates one embodiment of an introducer sheath for theapparatus of FIG. 1.

FIG. 10A illustrates an assembly view of the components included in analternative embodiment of the apparatus for closing openings formed inblood vessel walls.

FIG. 10B illustrates an assembly view of the components shown in FIG.10A, showing the reverse view of that shown in FIG. 10A.

FIG. 11A illustrates the assembled carrier assembly and triggeringassembly of the alternative embodiment of the apparatus shown in FIG.10A.

FIG. 11B illustrates a close-up view of the proximal end of theapparatus shown in FIG. 11A.

FIG. 12 illustrates the apparatus of FIG. 11A after advancement of thelocator assembly block.

FIG. 13A illustrates the apparatus of FIG. 12 after distal advancementof the triggering system and carrier assembly.

FIG. 13B illustrates a close-up view of the distal end of the housingand internal components of the apparatus shown in FIG. 13A.

FIG. 14A illustrates the apparatus of FIGS. 13A and 13B after furtherdistal advancement of the triggering system and carrier assembly.

FIG. 14B illustrates a close-up view of the distal end of the housingand internal components of the apparatus shown in FIG. 14A.

FIG. 15 illustrates a reverse view of the apparatus of FIGS. 11-14D,showing the locator release system.

FIG. 16 illustrates a side view of another alternative embodiment of anapparatus for closing openings formed in blood vessel walls.

FIG. 16A illustrates a close-up view of the distal end of the deviceshown in FIG. 16.

FIG. 17 illustrates a perspective view of the proximal end of the deviceshown in FIG. 16.

FIG. 17A illustrates a close-up view of the proximal end of the deviceshown in FIG. 17.

FIG. 18 illustrates a cross-sectional view of the device shown in FIG.16.

FIG. 18A illustrates a close-up cross-sectional view of a portion of thedevice shown in FIG. 18.

FIG. 18B illustrates a close-up cross-sectional view of a portion of thedevice shown in FIG. 18.

FIG. 19 illustrates a close-up cross-sectional view of the proximal endof the device shown in FIG. 16.

FIG. 20A is a cross-sectional side view illustrating an opening formedin a vessel, wherein a guidewire is shown disposed within the opening.

FIGS. 20B-20F are partial cross-sectional views illustrating thealternative embodiment of the closure device in accordance with thepresent invention wherein the device is illustrated being disposed overa guidewire.

FIG. 20G is a partial cross-sectional view illustrating the placement ofa closure element in accordance with the device illustrated in FIGS.20B-20F.

FIG. 21A illustrates one embodiment of a carrier assembly having asplitter and tubular members for delivering a closure element.

FIG. 21B illustrates one embodiment of a carrier member for the carrierassembly of FIG. 21A.

FIG. 21C illustrates one embodiment of a pusher member for the carrierassembly of FIG. 21A.

FIG. 21D illustrates one embodiment of a cover member for the carrierassembly of FIG. 21A.

FIG. 21E illustrates one embodiment of a support member for the carrierassembly of FIG. 21A.

FIG. 22A illustrates one embodiment of a carrier assembly for deliveringa closure element.

FIG. 22B illustrates one embodiment of a carrier member for the carrierassembly of FIG. 22A.

FIG. 22C illustrates one embodiment of a pusher member for the carrierassembly of FIG. 22A.

FIG. 22D illustrates one embodiment of a cover member for the carrierassembly of FIG. 22A.

FIG. 22E illustrates one embodiment of a support member having asplitter for the carrier assembly of FIG. 22A.

FIG. 23A illustrates one embodiment of a carrier member.

FIG. 23B illustrates one embodiment of a pusher member.

FIG. 24A illustrates one embodiment of a carrier member.

FIG. 24B illustrates one embodiment of a pusher member.

FIGS. 25A-25D illustrate embodiments of splitters for use with a carrierassembly.

FIG. 26 illustrates one embodiment of a splitter attached to a guidewire for use with a carrier assembly.

FIGS. 27A-27C illustrate embodiments of tissue-grabbing splitters foruse with a carrier assembly.

FIG. 28 illustrates an embodiment of a series of splitters configured tocombine and expand for use with a carrier assembly.

FIG. 29A illustrates an embodiment of a selectively expandable splitterin a collapsed orientation.

FIG. 29B illustrates the selectively expandable splitter of FIG. 29A inan expanded orientation.

FIG. 30A illustrates an embodiment of a selectively expandable splittermember in a collapsed orientation.

FIG. 30B illustrates the selectively expandable splitter member of FIG.30A in an expanded orientation.

FIG. 31A illustrates one embodiment of a carrier assembly having aslidable splitter that is splitting tubular members for delivering aclosure element into an opening formed in a wall of a blood vessel.

FIG. 31B illustrates the closure element of FIG. 31A being deployed overthe splitter so as to be capable of engaging tissue adjacent to theopening in the blood vessel wall.

FIG. 32A is a cross-sectional side view illustrating an opening formedin a vessel, wherein a guidewire coupled with an embodiment of atissue-grabbing splitter is shown disposed within the opening.

FIG. 32B illustrates the guidewire coupled with the tissue-grabbingsplitter of FIG. 32A, wherein the splitter is shown to be grabbingtissue disposed around the opening.

FIG. 32C illustrates an embodiment of a carrier assembly having a guidewire coupled with the tissue-grabbing splitter that is splitting tubularmembers for delivering a closure element over the splitter so as to becapable of engaging tissue adjacent to the opening in the blood vesselwall.

FIG. 32D illustrates the closure element of FIG. 32C drawing the engagedtissue substantially closed and/or sealed.

FIG. 33A is an orthogonal cross-sectional profile of a closure elementin a relaxed configuration.

FIG. 33B is a side view of the closure element of FIG. 33A.

FIG. 34A is an orthogonal cross-sectional profile of the closure elementof FIG. 33A in a deploying configuration.

FIG. 34B is a longitudinal cross-sectional profile of the closureelement of FIG. 33A in the deploying configuration.

FIG. 35A is an orthogonal cross-sectional profile of the closure elementof FIG. 33A in a retaining configuration.

FIG. 35B is a longitudinal cross-sectional profile of the closureelement of FIG. 33A in the retaining configuration.

FIG. 36A is a schematic representation of a closure element decreasingwhen being stretched from the deploying configuration of FIGS. 34A-34Bto the retaining configuration of FIGS. 35A-35B.

FIG. 36B is a schematic representation of a closure element changingfrom generally circular to generally oval when being stretched from thedeploying configuration of FIGS. 34A-34B to the retaining configurationof FIGS. 35A-35B.

FIGS. 37A-37D illustrate other clip configurations according to thepresent invention.

FIG. 38A illustrates one embodiment of a carrier assembly having tubularmembers for retaining and delivering a closure element.

FIG. 38B illustrates one embodiment of an offset carrier member for thecarrier assembly of FIG. 38A.

FIG. 38C illustrates one embodiment of a closure element in an offsetretaining configuration when retained by the carrier assembly of FIG.38A.

FIG. 38D illustrates one embodiment of an offset pusher member for thecarrier assembly of FIG. 38A.

FIG. 38E illustrates one embodiment of a cover member for the carrierassembly of FIG. 38A.

FIG. 38F illustrates one embodiment of a support member for the carrierassembly of FIG. 38A.

FIG. 39A illustrates one embodiment of a selectively expandable memberin a collapsed orientation for retaining a closure element.

FIG. 39B illustrates one embodiment of a selectively expandable memberin a selectively expanded orientation for deploying a closure element.

FIG. 40A illustrates one embodiment of a selectively expandable carriertube in a collapsed orientation for retaining a closure element.

FIG. 40B illustrates one embodiment of a selectively expandable tube ina selectively expanded orientation for deploying a closure element.

FIG. 40C illustrates one embodiment of a selectively expandable tube ina selectively expanded orientation for deploying a closure element.

FIG. 41A illustrates one embodiment of a carrier assembly having anexpandable member for delivering a closure element.

FIG. 41B illustrates one embodiment of a selectively expandable carriermember for the carrier assembly of FIG. 41A.

FIG. 41C illustrates one embodiment of a closure element in an offsetretaining configuration when held by the carrier assembly of FIG. 41A.

FIG. 41D illustrates one embodiment of an offset pusher member for thecarrier assembly of FIG. 41A.

FIG. 41E illustrates one embodiment of a cover member for the carrierassembly of FIG. 41A.

FIG. 41F illustrates one embodiment of a support member for the carrierassembly of FIG. 41A.

FIG. 42A is a cross-sectional side view illustrating an opening formedin a vessel, wherein a guidewire is shown disposed within the opening.

FIG. 42B illustrates the guidewire being used to deploy a locatorthrough the opening and locating the position of the vessel.

FIG. 42C illustrates an embodiment of a carrier assembly having offsettubular members for delivering a closure element in an offset retainingconfiguration so as to be capable of engaging tissue adjacent to theopening in the blood vessel wall.

FIG. 42D illustrates an embodiment of the closure element in a deployingconfiguration while being deployed from the carrier assembly.

FIG. 42E illustrates an embodiment of the closure element on a relaxedplanar configuration after being deployed from the carrier assembly.

FIG. 43A is a cross-sectional side view illustrating a carrier assemblyretaining a closure element in an offset retaining configuration andhaving a selectively expandable member in contracted orientation.

FIG. 43B is a cross-sectional side view illustrating a carrier assemblyretaining a closure element in an offset retaining configuration andhaving a selectively expandable member in an expanded orientation andbeing positioned for deploying the closure element into tissue around anopening in the tissue.

FIG. 43C illustrates an embodiment of the closure element in a retainingconfiguration being deployed over the expanded expandable member.

FIG. 43D illustrates an embodiment of the closure element being deployedfrom the expanded expandable member so as to engage the tissuesurrounding the opening.

FIG. 44 provides a general illustration of an apparatus for closingopenings formed in blood vessel walls constructed in accordance with thepresent invention.

FIG. 45 illustrates one embodiment of a delivery assembly for theapparatus of FIG. 44.

FIG. 46A illustrates a top view of one embodiment of a closure elementin a natural, planar configuration and with a natural cross-section foruse with the apparatus of FIG. 45, prior to curing.

FIG. 46B illustrates a side view of the closure element of FIG. 46A.

FIG. 46C illustrates a top view of the closure element of FIGS. 46A-46Bafter a natural cross-section of the closure element has been reduced,via a curing process.

FIG. 46D illustrates a side view of the closure element of FIG. 46C.

FIG. 46E illustrates a side view of the closure element of FIGS. 46C-46Das the closure element transitions from the natural, planarconfiguration to a tubular configuration.

FIG. 46F illustrates a top view of the closure element of FIGS. 46C-46Dupon completing the transition from the natural, planar configuration toa substantially tubular configuration, albeit a natural tubularconfiguration.

FIG. 46G illustrates a side view of the closure element of FIG. 46F.

FIG. 47A illustrates one embodiment of a distal locator portion and acarrier seat of a carrier assembly of FIG. 44, both of which areillustrated in an unexpanded state.

FIG. 47B illustrates the distal locator portion and the carrier seat ofFIG. 47A, both of which are illustrated in an expanded state.

FIG. 47C illustrates one embodiment of a proximal end region of thedelivery assembly of FIG. 44.

FIG. 48A illustrates one embodiment of a carrier assembly for theapparatus of FIG. 44.

FIG. 48B illustrates one embodiment of a pusher member for the carrierassembly of FIG. 48A.

FIG. 48C illustrates one embodiment of a cover member for the carrierassembly of FIG. 48A.

FIG. 49 illustrates a tube set and the delivery assembly of theapparatus of FIG. 44 mounted to a handle portion for operativemanipulation thereof.

FIG. 50A illustrates the closure element of FIGS. 46A-46G prior to beingdisposed upon the carrier assembly of FIG. 48A.

FIG. 50B illustrates the closure element of FIGS. 46A-46G upon beingdisposed upon the carrier assembly of FIG. 48A, and further as the covermember of FIG. 48C receives the carrier assembly.

FIG. 50C illustrates the closure element of FIGS. 46A-46G being retainedsubstantially within the carrier assembly of FIG. 48A when the carrierassembly is disposed substantially within the cover member of FIG. 48C.

FIG. 51A illustrates a sheath that is positioned through tissue and intoan opening formed in a wall of a blood vessel, in one embodiment of thepresent invention.

FIG. 51B illustrates the locator portion and the carrier assembly of thedelivery assembly of the apparatus being advanced distally into theblood vessel.

FIG. 51C illustrates a distal end region of the locator portion of FIG.51B extending into the blood vessel and being transitioned into anexpanded state.

FIG. 51D illustrates the distal end region of the locator portion ofFIG. 51C being retracted proximally to engage an inner surface of theblood vessel wall, and the retraction of the sheath to expose the tissueengaging device, in a tissue engaging condition.

FIG. 51E illustrates engagement of the tissue engaging device of theapparatus of FIG. 51D with the blood vessel wall.

FIG. 51F illustrates movement of the tissue engaging device from thetissue engaging condition to a closing condition.

FIG. 51G illustrates the closure element being deployed and engagingtissue adjacent to the opening in the blood vessel wall.

FIG. 51H illustrates the closure element of FIG. 51G transitioning fromthe substantially tubular configuration to the natural, planarconfiguration while engaging the engaged tissue.

FIG. 52 is a side elevation view, in cross-section, of anotherembodiment of the clip applier apparatus having a tissue engaging devicedeployed from a central lumen of the tubular body, in a tissue engagingcondition.

FIG. 53 is a side elevation view, in cross-section, of the clip applierapparatus of FIG. 52, illustrating the tissue engaging device in aclosing condition.

FIG. 54 is a side elevation view, in cross-section, of the clip applierapparatus of FIG. 52, illustrating deployment of the closure element.

FIG. 55 is a side elevation view, in cross-section, of yet anotherembodiment of the clip applier apparatus also having a tissue engagingdevice deployed from a central lumen of a tubular body, in a tissueengaging condition.

FIG. 56 is a side elevation view, in cross-section, of the clip applierapparatus of FIG. 55, illustrating the tissue engaging device in aclosing condition.

FIG. 57 is a side elevation view, in cross-section, of the clip applierapparatus of FIG. 55, illustrating deployment of the closure element.

FIG. 58 is a side elevation view, in cross-section, of anotherembodiment of the clip applier apparatus also having a tissue engagingdevice deployed from a central lumen of a tubular body, in a tissueclosing condition.

FIGS. 59A-59E are partial cross-sectional views illustrating the luminalplacement of a medical device for closing openings formed in bloodvessel walls with improved hemostasis.

FIGS. 60A-60B are side views illustrating an embodiment of an expandingmember for improving hemostasis during delivery of a closure device.

FIGS. 61A-61F are side views illustrating different embodiments ofexpanding members for improving hemostasis during delivery of a closuredevice.

FIGS. 62A-62B illustrate an anchor system in a collapsed configuration,and which can function as a locator.

FIG. 63 illustrates an anchor system being deployed and expanded withina vessel.

FIGS. 64A-64B show an anchor being collapsed and withdrawn.

FIGS. 65A-65C show an implantable “looped” anchor system being used witha carrier assembly and tube set that deploys a blood vessel closureelement.

FIGS. 66A-66B show an implantable coil anchor system being implantedwith a closure element.

FIGS. 67A-67B show examples of removable or implantable anchors, whichcan be used as locators.

FIG. 68A shows an expanded hemostasis member and an implantable anchorcooperating to provide hemostasis.

FIG. 68B shows the unexpanded hemostasis member and an implantableanchor as a closure element is about to be deployed.

It should be noted that the figures are not drawn to scale and thatelements of similar structures or functions are generally represented bylike reference numerals for illustrative purposes throughout thefigures. It also should be noted that the figures are only intended tofacilitate the description of the preferred embodiments of the presentinvention. The figures do not describe every aspect of the presentinvention and do not limit the scope of the invention.

DETAILED DESCRIPTION

The embodiments described herein extend to methods, systems, andapparatus for managing access through tissue. Some of the apparatuses ofthe present invention are configured to deliver a device for managingaccess through tissue into an opening formed in and/or adjacent totissue. Embodiments are additionally directed to an apparatus and methodfor delivering a closure element through tissue and into an openingformed in, or adjacent to, a wall of a blood vessel or other body lumenof any size.

The apparatus can be configured to receive and retain the closureelement such that the closure element is disposed substantially withinthe apparatus. Thereby, if the apparatus is introduced via an introducersheath, for example, the closure element can be disposed within, anddelivered by way of, a lumen of the introducer sheath. The apparatusalso is configured to engage the blood vessel wall adjacent to theopening and to position the closure element substantially adjacent to anouter surface of the blood vessel wall adjacent to the opening.

When properly positioned, the apparatus can be activated to distallydeploy the closure element. During deployment, the apparatus can beconfigured to substantially uniformly expand the closure element beyonda natural cross-section of the closure element such that the closureelement, when deployed, is configured to engage a significant amount ofthe blood vessel wall and/or tissue. Engaging the blood vessel walland/or tissue, the closure element can be further configured to returnto the natural cross-section. Thereby, the engaged blood vessel walland/or tissue are drawn substantially closed and/or sealed, such that,for example, hemostasis within the opening is enhanced.

Since current apparatuses for sealing openings formed in blood vesselwalls can snag tissue adjacent to the openings during positioning andmay not provide an adequate seal, an apparatus that is configured toprevent inadvertent tissue contact during positioning and to engage asubstantial of amount of tissue adjacent to the opening can prove muchmore desirable and provide a basis for a wide range of medicalapplications, such as diagnostic and/or therapeutic procedures involvingblood vessels or other body lumens of any size. This result can beachieved by employing a clip applier and associated methods of use inaccordance with the present invention.

Medical devices may be used in a variety of spaces. It may be desirableto generally reduce the size of medical devices. For example, stents maybe inserted into smaller and smaller vasculature, thus making itgenerally desirable to reduce the pre-deployment size of a stent. Inanother example, a closure device may be used to close tissue in, forexample, a body lumen. In order to reach the desired body lumen,typically a delivery device may be used to reach an access point in thebody lumen. To minimize the effects of a procedure on a patient, thereduction in size of the access point may be desirable.

When engaging tissue and/or closing openings in tissue, it may bedesirable to use a locator assembly to selectably contact a portion ofthe tissue. In some cases, the locator assembly may not contact aportion of the desired tissue. For example, the locator assembly may bepositioned within a body lumen but away from an inside surface of thebody lumen. In these instances, engagement of a portion of the desiredtissue may be less likely and/or favorable. It may be desirable toverify contact with a portion of the desired tissue during a medicalprocedure.

In one embodiment, a locator assembly may include engagement membersconfigured to engage a portion of the desired tissue. The locatorassembly may include a device to take measurements of a desiredmeasurable characteristic. The measurable characteristic may include,for example, impedance. Measurements may be taken when a portion of thelocator assembly is within a body lumen and when the locator assembly isbelieved to be in contact with tissue. Comparing the measurements takenwhen within the body lumen and when the locator assembly is believed tobe in contact with tissue may indicate that the locator assembly hascontacted a portion of the desired tissue. For example, an impedancemeasurement taken when within the body lumen may be higher than animpedance measurement taken when the locator assembly is in contact withtissue.

In a further embodiment, a surface engaging element can be provided. Thesurface engaging element may include a flexible body that may actuatebetween an expanded and relaxed configuration.

In some embodiments, an engagement portion of the surface engagingelement may include substantially uniform dimensions. In otherembodiments, the engagement portion of the surface engaging element mayinclude at least one non-uniform dimension. For example, the engagementportion may have a dimension that is larger than a support portion ofthe surface engaging element.

In further embodiments, the surface engaging element may be assembledusing a retaining portion. For example, an engagement portion may beconnected to a proximal, distal, and/or other portion of the surfaceengaging element by a retaining portion, such as a detent.

These results, whether individually or collectively, can be achieved,according to one embodiment of the present invention, by employingmethods, systems, and/or apparatus as shown in the figures and describedin detail below.

Since current apparatuses for sealing openings formed in blood vesselwalls can snag tissue adjacent to the openings during positioning andmay not provide an adequate seal, an apparatus that is configured toprevent inadvertent tissue contact during positioning and to engage asubstantial of amount of tissue adjacent to the opening can prove muchmore desirable and provide a basis for a wide range of medicalapplications, such as diagnostic and/or therapeutic procedures involvingblood vessels or other body lumens of any size. This result can beachieved, according to one embodiment of the present invention, byemploying an apparatus 100 as shown in FIG. 1.

FIG. 1 illustrates a clip applier apparatus 100 in accordance with thepresent invention. As will be discussed in more detail below, theapparatus 100 can deliver a closure element 500 (shown in FIGS. 6A-6B)through tissue 630 (shown in FIG. 8A) and into an opening 610 (shown inFIG. 8A) formed in and/or adjacent to a wall 620 (shown in FIG. 8A) of ablood vessel 600 (shown in FIG. 8A) or other body lumen. The closureelement (also referred to herein as a “clip”) 500 can have a generallyannular-shapes body 510 (shown in FIGS. 6A-6B) defining a channel 540and one or more barbs and/or tines 520 (shown in FIGS. 6A-6B) forreceiving and engaging the blood vessel wall 620 and/or the tissue 630around the opening 610. Although the closure element 500 has a naturalshape and size, the closure element 500 can be deformed into othershapes and sizes, as desired, and is configured to return to the naturalshape and size when released. For example, the closure element 500 canhave a natural, planar configuration with opposing tines 520 and anatural cross-section 530 as shown in FIGS. 6A-6B. The naturalcross-section 530 of the closure element 500 can be reduced to form areduced closure element 500′ that has a natural, planar configurationwith opposing tines 520 and a reduced cross-section 530′ as shown inFIGS. 6C-6D. By rotating the opposing tines 520 axially as shown in FIG.6E, the reduced closure element 500′ can be further deformed to form asubstantially tubular closure element 500″ (shown in FIG. 6F) having thereduced cross-section 530′ as well as being in a substantially tubularconfiguration with the tines 520 in an axial configuration.

Being configured to draw the blood vessel wall 620 and/or the tissue 630adjacent to the opening 610 substantially closed and/or to enhancehemostasis within the opening 610, the closure element 500 can be formedfrom any suitable material, including any biodegradable material, anyshape memory alloy, such as alloys of nickel-titanium, or anycombination thereof. Additionally, it is contemplated that the closureelement may be coated with a beneficial agent or be constructed as acomposite, wherein one component of the composite would be a beneficialagent. As desired, the closure element 500 may further includeradiopaque markers (not shown) or may be wholly or partially formed froma radiopaque material to facilitate observation of the closure element500 using fluoroscopy or other imaging systems. Exemplary embodiments ofa closure element are disclosed in U.S. Pat. Nos. 6,197,042, and6,623,510, and in co-pending application Ser. Nos. 09/546,998,09/610,238, and 10/081,726. The disclosures of these references and anyothers cited therein are expressly incorporated herein by reference.

The apparatus 100 can be configured to receive and retain the closureelement 500 such that the closure element 500 is disposed substantiallywithin the apparatus 100. Thereby, if the apparatus 100 is introducedvia an introducer sheath 640 (shown in FIG. 8A), for example, theclosure element 500 can be disposed within, and delivered by way of, alumen 644 (shown in FIG. 8A) of the introducer sheath 640. The apparatus100 also can be configured to engage the blood vessel wall 620 adjacentto the opening 610. Being disposed substantially within the apparatus100, the closure element 500 can deeply penetrate, without inadvertentlycontacting, tissue 630 adjacent to the opening 610 such that theapparatus 100 can position the closure element 500 substantiallyadjacent to an outer surface 620 a (shown in FIG. 8A) of the bloodvessel wall 620 adjacent to the opening 610.

When properly positioned, the apparatus 100 can be activated to deploythe closure element 500. The apparatus 100 can be configured tosubstantially uniformly expand the closure element 500 beyond thenatural cross-section 530 of the closure element 500 during deployment,the apparatus 100, as desired, and/or can deploy the closure element 500without expanding the closure element 500. The closure element 500, whendeployed, can be configured to engage a significant amount of the bloodvessel wall 620 and/or tissue 630 adjacent to the opening 610. Engagingthe blood vessel wall 620 and/or tissue 630, the closure element 500 isfurther configured to return to the natural cross-section 530. Thus, theengaged blood vessel wall 620 and/or tissue 630 can be drawnsubstantially closed and/or sealed, such that, for example, hemostasiswithin the opening 610 is enhanced.

The apparatus 100 can be provided as one or more integrated componentsand/or discrete components. As shown in FIG. 1, for example, theapparatus 100 can include a locator (or obturator) assembly 200 and acarrier assembly 300. For purposes of illustration, the locator assembly200 and the carrier assembly 300 are shown in FIG. 1 as includingsubstantially separate assemblies. As desired, however, the locatorassembly 200 and the carrier assembly 300 each can be provided, in wholeor in part, as one or more integrated assemblies.

Being configured to extend into the opening 610, the locator assembly200 can selectably contact the inner surface 620 b of the blood vesselwall 620 adjacent the opening 610. Whereby, the locator assembly 200 canbe configured to draw the blood vessel wall 620 taut and maintain theproper position of the apparatus 100 in relation to the opening 610 asthe blood vessel 600 pulsates. The locator assembly 200 can be providedin the manner disclosed in co-pending application Ser. Nos. 09/732,835and 10/081,723, the disclosures of which are expressly incorporatedherein by reference. The locator assembly 200 can include a flexible orsemi-rigid tubular body 210. As illustrated in FIG. 2A, the tubular body210 has a proximal end region 210 a and a distal end region 210 b andincludes a predetermined length 218 a and a predetermined outercross-section 218 b, both of which can be of any suitable dimension. Thedistal end region 210 b of the locator assembly 200 can include asubstantially rounded, soft, and/or flexible distal end or tip 220 tofacilitate atraumatic advancement and/or retraction of the distal endregion 210 b into the blood vessel 600. As desired, a pigtail (notshown) may be provided on the distal end 220 to further aid atraumaticadvancement of the distal end region 210 b.

The distal end region 210 b of the locator assembly 200 further can beselectably controllable between an unexpanded state and an expandedstate. In the unexpanded state, the distal end region 210 b has anunexpanded size; whereas, the distal end region 210 b in the expandedstate has an expanded size, which is greater than the unexpanded size ofthe distal end region 210 b in the unexpanded state. The distal endregion 210 b can be configured to expand from the unexpanded size to theexpanded size and/or to contract from the expanded size to theunexpanded size, and the expansion and contraction of the distal endregion 210 b can be substantially uniform about a longitudinal axis ofthe locator assembly 200. For example, one or more expansion elements230 can be provided on the distal end region 210 b and can be configuredto expand substantially transversely with respect to a longitudinal axisof the locator assembly 200. The expansion elements 230 can besubstantially equally distributed about an outer periphery 212 of thedistal end region 210 b. Optionally, the expansion elements 230 mayinclude radiopaque markers (not shown) or may be wholly or partiallyformed from a radiopaque material to facilitate observation of theexpansion elements 230 and/or the distal end region 210 b usingfluoroscopy or other imaging systems.

At least one (and, at least in some cases, all) of the expansionelements 230 can include a substantially flexible member 230′ with asubstantially fixed end region 230 a′, an intermediate region 230 b′,and a movable end region 230 c′ as shown in FIGS. 2B-2C. For eachsubstantially flexible member 230′, the fixed end region 230 a′ can befixedly coupled with the distal end region 210 b; whereas, the movableend region 230 c′ can be movably coupled with the distal end region 210b and configured to be axially movable relative to the fixed end region230 a′. When each movable end region 230 c′ can be axially moved towardthe relevant fixed end region 230 a′, the intermediate regions 230 b′buckle and/or expand transversely outwardly, thereby transitioning thedistal end region 210 b of the locator assembly 200 from the unexpandedstate to the expanded state. In contrast, the distal end region 210 btransitions from the expanded state to the unexpanded state as each ofthe movable end regions 230 c′ are axially moved away from the relevantfixed end region 230 a′. Although the expansion elements 230 are shownas including the flexible members 230′ in FIGS. 2B-2C for purposes ofillustration, it is understood that the expansion elements 230 caninclude any type of expansion elements and are not limited to theillustrated embodiments. It is further contemplated that the expansionelements 230 may further include geometric features that allow/enhancethe ability of the expansion elements to bend or fold from a retractedposition to an expanded position. The expansion elements may beconstructed of a material such as steel, spring steel, plastics orcomposites. In one embodiment, the expansion elements are constructed ofNitinol®.

FIGS. 2B′ and 2C′ illustrate an alternative embodiment of a locatorassembly 200″ for locating a surface of a body lumen, in accordance withthe present invention. The locator assembly 200″ of this embodiment maybe functionally similar to that of the locator assembly 200 previouslydescribed above and shown in FIGS. 2B and 2C in most respects, whereincertain features will not be described in relation to this embodimentwherein those components may function in the manner as described aboveand are hereby incorporated into this alternative embodiment describedbelow. Like structures and/or components are given like referencenumerals.

The locator assembly 200″ may be located proximal to a distal end 210 b″of a tubular member 210″ and/or an apparatus (such as apparatus 100shown in FIG. 1). The locator assembly 200″ may include a surfaceengagement assembly 226″. The surface engagement assembly 226″ mayinclude a distal end portion 226 a″, a proximal end portion 226 b″,and/or at least one surface engagement element 230″. The surfaceengagement elements 230″ may be configured to transition from a relaxedstate to an expanded state, similar to the substantially flexible member230′ described above. For example, the surface engagement elements 230″may be moveably connected to and/or fixedly connected to a distal endregion 210 b″ of the locator assembly 200″. In this example, a distalend 230 a″ of the surface engagement elements 230″ may be moveablyconnected to a proximal end 230 c″ of the surface engagement elements230″ may be fixedly connected to the distal end region 210 b″. In otherexamples, other types of connections may be contemplated.

The locator assembly 200″ may include two, three, four, and/or othernumbers of surface engaging elements 230″. At least one of the surfaceengaging elements 230″ may be configured to conduct a measurablecharacteristic of the surface engaging elements 230″ to the locatorassembly 200″. For instance, the locator assembly 200″ may be incommunication with a measuring device 251. An example of a measuringdevice 251 may include an impedance measuring device, a volt meter, anamp meter, a pressure transducer, piezoelectric crystals, othermeasuring devices, or combinations thereof. The measuring device 251 maydetermine changes in measurable characteristics of the locator assembly200″. For instance, the measuring device 251 may measure changes in theimpedance of the locator assembly 200″. In another example, themeasuring device 251 may determine changes in pressure. Changes inpressure may be determined by a pressure transducer or other pressuremeasuring device. In a further example, the measuring device 251 mayretrieve ultrasonic data in and/or around the body lumen. Ultrasonicdata may be retrieved by piezoelectric crystal or other ultrasonic datagathering device. Other measurable characteristics may includeelectrical characteristics such as voltage, current, other electricalcharacteristics, and/or other measurable characteristics.

In embodiments where the measurable characteristic is an electricalcharacteristic, the locator assembly 200″ may be in electricalcommunication with at least one of the surface engaging elements 230″.In the present embodiment, the locator assembly 200″ may include atleast one distal conductive portion 204 a″ and/or at least one proximalconductive portion 204 b″ with which at least one surface engagingelement 230″ may be in electrical communication. At least one of surfaceengaging elements 230″ may be formed at least partially from anelectrically conductive material. In the present embodiment, at leastone of surface engaging elements 230″ may be formed at least partiallyfrom Nitinol®.

The distal conductive portions 204 a″ and/or the proximal conductiveportions 204 b″ may be in electrical communication with the measuringdevice 251. For example, the at least one distal conductive portion 204a″ may be in electrical communication with the measuring device 251through at least one distal conductor connector 205 a″ and/or the atleast one proximal conductive portion 204 b″ may be in electricalcommunication with the measuring device 251 through at least oneproximal conductor connector 205 b″. The distal and/or proximalconductor connectors 205 a″, 205 b″ may extend toward the distal end 210b″ and/or toward a proximal end 210 a″ of the tubular member 210″through at least one lumen (not shown).

In the present embodiment, each of the surface engaging elements 230″may be in electrical communication with a different distal conductiveportion 204 a″ and/or proximal conductive portion 204 b″. Alternatively,more than one surface engaging element 230″ may be in electricalcommunication with the same distal conductive portion 204 a″ and/orproximal conductive portion 204 b″. Other combinations are alsocontemplated.

The surface engaging elements 230″ may be in electrical communicationwith each other. For instance, two or more surface engaging elements230″ may be may be formed from the same piece of material. In thepresent embodiment, each of the surface engaging elements 230″ may beselectively electrically isolated from each other. Isolation of thesurface engaging elements 230″ may be accomplished by insulators 206 a″,206 b″. The insulators 206 a″, 206 b″ may include materials such asceramics, polyethylene, and/or other insulating materials.

FIGS. 2B″ and 2C″ illustrate a further embodiment of a locator assembly200″″ for locating a surface of a body lumen, in accordance with thepresent invention. The locator assembly 200′″ of this embodiment may befunctionally similar to that of the locator assemblies 200, 200″previously described above and shown in FIGS. 2B-2C and 2B′-2C′ in mostrespects, wherein certain features will not be described in relation tothis embodiment wherein those components may function in the manner asdescribed above and are hereby incorporated into this alternativeembodiment described below. Like structures and/or components are givenlike reference numerals. For example, the locator assembly 200′″ may beconfigured to facilitate the determination of changes in measurablecharacteristics of the locator assembly.

The locator assembly 200′″ may be located proximal to a distal end of atubular member (such as 210 b, 210 b″ shown in FIGS. 2A, 2B, 2A′, and2B′) and/or an apparatus (such as apparatus 100 shown in FIG. 1). Thelocator assembly 200′″ may include a surface engagement assembly 226′″.

The surface engagement assembly 226′″ may include a distal end portion226 a′″, a proximal end portion 226 b′″, and/or at least one surfaceengagement element 230′″. In the present embodiment, the surfaceengagement assembly 226′″ may include four surface engagement elements230′″ that may be separated by a distal and/or proximal engagementelement support 231 a′″, 231 b′″. The distal and/or proximal engagementelement supports 231 a′″, 231 b′″ may electrically insulate the surfaceengagement elements 230′″. In an alternative embodiment, the distalengagement element supports 231 a′″, proximal engagement elementsupports 231 b″, and/or surface engagement elements 230′″ may be formedas a unitary piece and/or from the same material. For example, thedistal engagement element supports 231 a′″, proximal engagement elementsupports 231 b′″, and/or surface engagement elements 230′″ may be lasercut from a Nitinol® tube.

The surface engagement elements 230′″ may include a distal and/orproximal retaining portion 229 a′″, 229 b′″. The distal and/or proximalretaining portions 229 a′″, 229 b′″ may include an aperture and/or otherretaining mechanism that may receive, for example, a detent and/or otherretaining mechanism. For instance, a cover member (such as the covermember 220 shown in FIG. 2C) may include a retaining mechanism (notshown) to limit motion between the cover member and the surfaceengagement elements 230′″. The cover member may be connected to acontrol member (such as control member 250 shown in FIG. 2D) that isconfigured to transition the surface engagement elements 230′″ from arelaxed state to an expanded state, similar to the substantiallyflexible member 230′ described above.

The surface engaging elements 230′″ may include a measuring component253″. The measuring component 253′″ may facilitate the determination ofchanges in measurable characteristics of the locator assembly 200′″. Forinstance, the measuring component 253′″ may facilitate the determinationof changes in impedance, pressure, ultrasonic data, or other measurablecharacteristics. The measuring component 253′″ may be in electricalcommunication with a connector 205′″. The connector 205′″ may be inelectrical communication with a measuring device (shown as 251 in FIG.2B′).

FIGS. 2B′″ and 2C′″ illustrate a further embodiment of a locatorassembly 200″″ for locating a surface of a body lumen, in accordancewith the present invention. The locator assembly 200″″ of thisembodiment may be functionally similar to that of the locator assemblies200, 200′, 200″, 200′″ previously described above and shown in FIGS.2B-2C, 2B′-2C′, and 2B″-2C″ in most respects, wherein certain featureswill not be described in relation to this embodiment wherein thosecomponents may function in the manner as described above and are herebyincorporated into this alternative embodiment described below. Likestructures and/or components are given like reference numerals.

The locator assembly 200″″ may be located proximal to a distal end of atubular member (such as 210 b, 210 b″ shown in FIGS. 2A, 2B, 2A′, and2B′) and/or an apparatus (such as apparatus 100 shown in FIG. 1). Thelocator assembly 200″″ may include a surface engagement assembly 226″″,a cover member 220″″, and/or a proximal end portion 226 b″″.

The cover member 220″″ and/or proximal end portion 226 b″″ may include adistal retaining portion 221 a″″ and/or a proximal retaining portion 221b″″, respectively. The surface engagement assembly 226″″ may include atleast one surface engagement element 230″″. The surface engagementelements 230″″ may include a distal and/or proximal retaining portion229 a″″, 229 b″″. The distal and/or proximal retaining portions 221 a″″,221 b″″ on the cover member 220″″ and/or proximal end portion 226 b″″may include an aperture and/or other retaining mechanism that maycooperate with corresponding distal and/or proximal retaining portions229 a″″, 229 b″″, such as a detent and/or other retaining mechanism, onthe surface engagement elements 230″″ to limit motion between the covermember 220″″, the proximal end portion 226 b″″, and/or the surfaceengagement elements 230″″. The distal and/or proximal retaining portions229 a″″, 229 b″″ may be located near a distal and/or proximal end 230a″″, 230 b″″ of the surface engagement element 230″″, respectively.

A control member 250″″ may be inserted through the proximal end portion226 b″″ and/or may be connected to the cover member 220″″. The controlmember 250″″ may be used to transition the surface engagement elements230″″ from a relaxed state to an expanded state, similar to thesubstantially flexible member 230′ described above.

In the present embodiment, the control member 250″″ may be a singlepiece, which may be elongate from the cover member 220″″ toward aproximal end (such as proximal end 210 a″ shown in FIG. 2B′) of thelocator assembly 200″″. Alternatively, the control member 250″″ may bein one or more pieces that may be connected together using variousmechanisms, similar to the retaining portions 221 a″″, 221 b″″, 229 a″″,229 b″″ described above.

The proximal end portion 226 b″″ may include a tubular member retainingportion 228″″. The tubular member retaining portion 228″″ may beconfigured to engage a distal end (such as distal end 210 b, 210 b″shown in FIGS. 2B and 2B′). The tubular member retaining portion 228″″,in the present embodiment, may include a ramp and/or other retainingmechanism to limit the motion of the tubular member in at least onedirection.

The surface engagement elements 230″″ may include an engagement member232″″. The engagement member 232″″ may include an engagement portion234″″ and/or an engagement support portion 237″″.

The engagement portion 234″″ may be configured to contact and/or engagetissue. The engagement portion 234″″, in the present embodiment, may beenlarged in an intermediate portion 235″″ in comparison to distal and/orproximal end 234 a″″, 234 b″″ of the engagement portion 234″″. Anenlarged intermediate portion 235″″ may facilitate contact and/orengagement with tissue.

The engagement support portion 237″″ may support the engagement portion234″″ during, for example, transitioning from a relaxed state to anexpanded state. The engagement support portion 237″″ may include anenlarged intermediate portion 238″″, similar to the enlargedintermediate portion 235″″ of the engagement portion 234″″. Having anenlarged intermediate portion 238″″ on the engagement support portion237″″ may add stability to the engagement portion 234″″ while in theexpanded state.

The intermediate portions 235″″, 238″″ of the engagement portions 234″″and/or the engagement support portions 237″″ may be oval shaped.Alternatively, the intermediate portions 235″″, 238″″ may have the sameshape, have differing shapes, and/or have other combinations of shapes.

In the present embodiment, the proximal end 234 b″″ of the engagementportion 234″″ may be connected to a proximal support portion 233″″. Theproximal support portion 233″″ may be connected to the proximal endportion 226 b″″ and may separate the engagement portion 234″″ from theproximal end portion 226 b″″. The distal end 234 a″″ of the engagementportion 234″″ may be connected to an intermediate support portion 236″″.The intermediate support portion 236″″ may be connected to the proximalend 237 b″″ of the engagement support portion 237″″ and may separate theengagement portion 234″″ from the engagement support portion 237″″. Thedistal end 237 a″″ of the engagement support portion 237″″ may beconnected to a distal support portion 239″″. The distal support portion239″″ may be connected to the distal end (not shown) of the surfaceengagement element 230″″ and may separate the engagement support portion237″″ from the distal end portion 226 a″″.

The surface engaging elements 230″″ may include a measuring component253″″. The measuring component 253″″ may facilitate the determination ofchanges in measurable characteristics of the locator assembly 200″″. Forinstance, the measuring component 253″″ may facilitate the determinationof changes in impedance, pressure, ultrasonic data, or other measurablecharacteristics. The measuring component 253″″ may be in electricalcommunication with a connector 205″″. The connector 205″″ may be inelectrical communication with a measuring device (shown as 251 in FIG.2B′).

Referring now to FIG. 2D, the locator assembly 200 may further include alocator control system associated with the locator assembly. As shown inFIG. 2D, the locator control system 240 can be associated with theproximal end region 210 a of the locator assembly 200 and can beconfigured to selectively control the distal end region 210 b of thelocator assembly 200 between the unexpanded and expanded states. Thelocator control system 240 can selectively control the distal end region210 b between the unexpanded and expanded states, such as by beingactivated by a switching system (not shown). For example, a controlmember 250, such as a rod, wire, or other elongate member, can bemoveably disposed within a lumen (not shown) formed by the tubular body210 and extending substantially between the proximal end region 210 aand the distal end region 210 b. The control member 250 has a proximalend region 250 a that is coupled with the locator control system 240,which can be via a control block 260 (shown in FIG. 4D), and a distalend region (not shown) that is coupled with the distal end region 210 bof the locator assembly 200, the expansion elements 230, and/or themovable end regions 230 c′ of the substantially flexible members 230′.The locator control system 240 can selectively transition the distal endregion 210 b, the expansion elements 230, and/or the substantiallyflexible members 230′ between the unexpanded and expanded states bymoving the control member 250 axially relative to the tubular body 210.

The locator control system 240 further includes a locator release system490 for maintaining the unexpanded state and/or the expanded state ofthe distal end region 210 b, the expansion elements 230, and/or thesubstantially flexible members 230′. The locator release system 490 canbe configured to maintain the expanded state of the distal end region210 b, and can include any type of locking system and can be engaged,for instance, by activating the switching system. For example, once thesubstantially flexible members 230′ have entered the expanded state, thelocator release system 490 can secure the control member 250 to preventaxial movement relative to the tubular body 210, thereby maintaining thesubstantially flexible members 230′ in the expanded state.

In the manner described in more detail below, the locator control system240 also can be configured to disengage the locator release system 490,such that the distal end region 210 b, the expansion elements 230,and/or the substantially flexible members 230′ can transition betweenthe expanded and unexpanded states. The locator release system 490 canbe disengaged, for example, by activating an emergency release system(not shown). As desired, the locator control system 240 may furtherinclude a biasing system (not shown), such as one or more springs orother resilient members, to bias the distal end region 210 b, theexpansion elements 230, and/or the substantially flexible members 230′to enter and/or maintain the unexpanded state when the locator releasesystem 490 is disengaged.

Returning to FIG. 1, the carrier assembly 300 can be coupled with, andslidable relative to, the locator assembly 200. The carrier assembly 300is configured to receive and retain the closure element 500 (shown inFIGS. 6A-6B), which can be disposed substantially within the carrierassembly 300. When the locator assembly 200 engages the inner surface620 b (shown in FIG. 8A) of the blood vessel wall 620 (shown in FIG.8A), the carrier assembly 300 can be further configured to position theclosure element 500 substantially adjacent to the opening 610 (shown inFIG. 8A) and to deploy the closure element 500. Upon being deployed, theclosure element 500 can maintain the reduced cross-section 530′ (shownin FIGS. 6C-6D), and can temporarily and substantially uniformly expandbeyond the natural cross-section 530 (shown in FIGS. 6A-6B) of theclosure element 500. In either case, the closure element 500, whendeployed, can engage a significant amount of the blood vessel wall 620and/or tissue 630 adjacent to the opening 610. Thereafter, the closureelement 500 can be configured to return to the natural cross-section 530such that the blood vessel wall 620 and/or tissue 630 is drawnsubstantially closed and/or sealed.

Turning to FIGS. 3A-3D, the carrier assembly 300 can include a tube set305, including a carrier member 310, a pusher member 320, a support tube340, and a cover member 330. The carrier member 310, the pusher member320, the support tube 340, and the cover member 330 can be provided as aplurality of nested, telescoping members with a common longitudinal axis350 as illustrated in FIG. 3A. The carrier member 310 can be configuredto receive and support the closure element 500. While being disposed onthe carrier member 310, the closure element 500 can be deformed from thenatural, planar configuration to form the substantially tubular closureelement 500″ (shown in FIGS. 6F-6G) as will be discussed in more detailbelow. Being disposed substantially about, and supported by, an outerperiphery 312 b of the carrier member 310, the substantially tubularclosure element 500″ can be substantially in axial alignment with thecarrier member 310 with the tines 520 pointed substantially distally.

The carrier member 310 can be formed as a substantially rigid,semi-rigid, or flexible tubular member. Additionally, the carrier member310 can have a proximal end region 310 a and a distal end region 310 band includes a predetermined length 318 a and a predeterminedcross-section 318 b, both of which can be of any suitable dimension. Thecarrier member 310 also can define a lumen 314 that extendssubstantially between the proximal end region 310 a and the distal endregion 310 b and that is configured to slidably receive at least aportion of the tubular body 210 of the locator assembly 200. Althoughthe cross-section 318 b of the carrier member 310 generally issubstantially uniform, the distal end region 310 b of the carrier member310 can have a cross-section that increases distally, as illustrated inFIGS. 3A-3B, for substantially uniformly expanding the substantiallytubular closure element 500″ beyond the natural cross-section 530 of theclosure element 500 when the substantially tubular closure element 500″is deployed. To deploy the closure element 500 without expanding theclosure element 500, the distal end region 310 b can be formed with across-section (not shown) that is substantially uniform. Although shownand described as having the cross-section that increases distally forexpanding the substantially tubular closure element 500″, it will beunderstood that the distal end region 310 b of the carrier member 310can be provided with the substantially-uniform cross-section and thatthe substantially tubular closure element 500″ can be deployed withoutbeing expanded.

Being configured to distally deploy the substantially tubular closureelement 500″, the pusher member 320 has a proximal end region 320 a anda distal end region 320 b and is coupled with, and slidable relative to,the carrier member 310. The pusher member 320 includes a predeterminedlength 328 a and a predetermined cross-section 328 b, both of which canbe of any suitable dimension and can be configured to slidably receivethe carrier member 310 such that the distal end region 320 b of thepusher member 320 is offset proximally from the distal end region 310 bof the carrier member 310. As desired, the predetermined length 328 a ofthe pusher member 320 can be greater than or substantially equal to thepredetermined length 318 a of the carrier member 310. The predeterminedlength 328 a of the pusher member 320, however, can be less than thepredetermined length 318 a of the carrier member 310 such that thecarrier member 310 and the pusher member 320 at least partially define aspace 360 distal to the distal end region 320 b of the pusher member 320and along the periphery 312 b of the carrier member 310.

Being formed from a substantially rigid, semi-rigid, or flexiblematerial, the pusher member 320 can be substantially tubular and candefine a lumen 324 that extends substantially between the proximal endregion 320 a and the distal end region 320 b and that is configured toslidably receive at least a portion of the carrier member 310. Thecross-section 328 b of the pusher member 320 can be substantiallyuniform, and the distal end region 320 b of the pusher member 320 caninclude one or more longitudinal extensions 325, which extend distallyfrom the pusher member 320 and along the periphery 312 b of the carriermember 310 as shown in FIG. 3C. The longitudinal extensions 325 can bebiased such that the longitudinal extensions 325 extend generally inparallel with common longitudinal axis 350. The longitudinal extensions325 are sufficiently flexible to expand radially, and yet sufficientlyrigid to inhibit buckling, as the distal end region 320 b is directeddistally along the carrier member 310, and to engage thedistally-increasing cross-section of the distal end region 310 b of thecarrier member 310 to deploy the substantially tubular closure element500″.

A cover member 330 is configured to retain the substantially tubularclosure element 500″ substantially within the carrier assembly 300 priorto deployment as shown in FIG. 3D. Being coupled with, and slidablerelative to, the pusher member 320, the cover member 330 has a proximalend region 330 a and a distal end region 330 b and includes apredetermined length 338 a and a predetermined cross-section 338 b, bothof which can be of any suitable dimension. The cover member 330 can beformed as a substantially rigid, semi-rigid, or flexible tubular member.Additionally, the cover member 330 can have an inner periphery 332 a andan outer periphery 332 b and can define a lumen 334. The lumen 334 canextend substantially between the proximal and distal end regions 330 a,330 b of the cover member 330 and can be configured to slidably receiveat least a portion of the pusher member 320. When the cover member 330is properly positioned within the carrier assembly 300, the distal endregion 330 b can be configured to extend over the space 360, therebydefining an annular cavity 370 for receiving and retaining thesubstantially tubular closure element 500″.

The cross-section 338 b of the cover member 330 can be substantiallyuniform, and the distal end region 330 b of the cover member 330 caninclude one or more longitudinal extensions 335, which extends distallyfrom the cover member 330 and along an outer periphery 322 b of thepusher member 320 as shown in FIG. 3D. Although the longitudinalextensions 335 can extend generally in parallel with common longitudinalaxis 350, the longitudinal extensions 335 can be biased such that theplurality of longitudinal extensions 335 extends substantially radiallyinwardly as illustrated in FIGS. 3A and 3D. Thereby, the longitudinalextensions 335 can at least partially close the lumen 334 substantiallyadjacent to the distal end region 330 b of the cover member 330. Topermit the substantially tubular closure element 500″ to be deployedfrom the annular cavity 370, the longitudinal extensions 335 can besufficiently flexible to expand radially to permit the distal end region310 b of the carrier member 310 to move distally past the cover member330 to open the annular cavity 370 such that the distal end region 330 bno longer extends over the space 360.

If the carrier assembly 300 is assembled as the plurality of nested,telescoping members as shown in FIG. 3A, the carrier member 310 can beat least partially disposed within, and slidable relative to, the lumen324 of the pusher member 320 as shown in FIG. 3C. The pusher member 320,in turn, can be at least partially disposed within, and slidablerelative to, the lumen 334 of the cover member 330. To couple thecarrier assembly 300 with the locator assembly 200, the tubular body 210of the locator assembly 200 can be at least partially disposed within,and slidable relative to, the lumen 314 of the carrier member 310. Thelongitudinal axis of the locator assembly 200 can be substantially inaxial alignment with the common longitudinal axis 350 of the carriermember 310, the pusher member 320, the cover member 330, and the supporttube 340.

It will be appreciated that the tube set 305 can also include a supportmember 340 as shown in FIGS. 3A and 3E. The support member 340 isconfigured to slidably receive the tubular body 210 of the locatorassembly 200 and to provide radial support for the distal end region 210b of the tubular body 210 when the locator assembly 200 is coupled withthe carrier assembly 300. The carrier assembly 300 can advantageouslyinclude the support member 340, for example, if the tubular body 210 isnot sufficiently rigid or under other circumstances in which support forthe tubular body 210 might be desirable. It also will be appreciatedthat the support member 340 also can be configured to inhibit theplurality of longitudinal extensions 335, which extend from the distalend region 330 b of the cover member 330, from expanding prematurelyprior to the closure element 500 being deployed.

The support member 340 can be formed as a substantially rigid,semi-rigid, or flexible tubular member, having a proximal end region 340a and a distal end region 340 b. Wherein an outer periphery 342 b of thesupport member 340 can define a lumen 344 that extends substantiallybetween the proximal end region 340 a and the distal end region 340 b,the lumen is configured to slidably receive and support at least aportion of the tubular body 210 of the locator assembly 200. The supportmember 340, in turn, can be at least partially slidably disposed withinthe lumen 314 of the carrier member 310 such that the tubular body 210of the locator assembly 200 may be coupled with, and slidable relativeto, the carrier member 310 in the manner described in more detail above.The support member 340 can have a predetermined length 348 a and apredetermined cross-section 348 b, both of which can be of any suitabledimension, and the cross-section 348 b can be substantially uniform.Although shown and described as being substantially separate forpurposes of illustration, it will be appreciated that the carrier member310, the pusher member 320, the cover member 330, and/or the supportmember 340 can be provided, in whole or in part, as one or moreintegrated assemblies.

The carrier assembly 300 may further include a housing 380 asillustrated in FIG. 4A. The housing 380 can be formed as an elongatemember with a longitudinal axis 386. Additionally, the housing 380 canhave an outer periphery 382 b and includes a proximal end region 380 aand a distal end region 380 b. Thereby, when the apparatus 100 can beproperly assembled, the tubular body 210 of the locator assembly 200 atleast partially disposed within the tube set 305 such that the distalend region 210 b of the tubular body 210 extends beyond the distal endregions 310 b, 320 b, 330 b, and/or 340 b. The tubular body 210, thecarrier member 310, the pusher member 320, the cover member 330, and, ifprovided, the support member 340 can be at least partially disposedwithin, and slidable relative to, the housing 380, and the respectivedistal end regions 210 b, 310 b, 320 b, 330 b, and 340 b extend from thedistal end region 380 b of the housing 380 such that the commonlongitudinal axis 350 (shown in FIG. 3A) of the tube set 305 issubstantially axially aligned with the longitudinal axis 386 of thehousing 380. Being configured to slidably retain the respective proximalend regions 210 a, 310 a, 320 a, 330 a, and 340 a, the housing 380supports the tube set 305 and can have one or more handles 390 tofacilitate use of the apparatus 100. The handles 390 extendsubstantially radially from the outer periphery 382 b of the housing 380and can be provided in the manner known in the art.

When the apparatus 100 is properly assembled, the tubular body 210 ofthe locator assembly 200 can be at least partially disposed within thetube set 305 of the carrier assembly 300 such that the distal end region210 b of the tubular body 210 extends beyond the distal end regions 310b, 320 b, 330 b, and/or 340 b. Further, the proximal end region 210 a ofthe tubular body 210 and the proximal end regions 310 a, 320 a, 330 a,and/or 340 a of the tube set 305 are at least partially disposed within,and slidable relative to, the housing 380. The switching system of thelocator assembly 200 and a switching system 450 of the triggering system400 can be accessible external to the housing 380 as shown in FIGS. 4Aand 4C.

Turning to FIGS. 4B-4D, a triggering system 400 can be disposedsubstantially within the housing 380. The triggering system 400 can beconfigured to control the relative axial movement and/or positioning ofthe respective distal end regions 310 b, 320 b, 330 b, and 340 b of thetube set 305 and/or the distal end region 210 b of the locator assembly200. Being coupled with the proximal end regions 210 a, 310 a, 320 a,330 a, and/or 340 a, the triggering system 400 can control the relativeaxial movement of the distal end regions 210 b, 310 b, 320 b, 330 b,and/or 340 b in any manner, such as by being activated by the switchingsystem 450. As desired, the triggering system 400 can induce axialmotion, such as distal motion, with respect to one or more of the distalend regions 210 b, 310 b, 320 b, 330 b, and/or 340 b. One or more of thedistal end regions 210 b, 310 b, 320 b, 330 b, and/or 340 b can beaxially moved. Axial motion of one or more of the carrier member 310,the pusher member 320, the cover member 330, and the support member 340and/or the tubular body 210 can be attained, for example, by applying anaxial force to the switching system 450. To facilitate monitoring of thepositioning of the carrier assembly 300 and/or the substantially tubularclosure element 500″, one or more of the distal end regions 210 b, 310b, 320 b, 330 b, and/or 340 b may include radiopaque markers (not shown)or may be wholly or partially formed from a radiopaque material.

The triggering system 400 can be configured to overcome internalresistance such that the relative axial movement and/or positioning ofthe respective distal end regions 310 b, 320 b, 330 b, and 340 b of thetube set 305 and/or the distal end region 210 b of the locator assembly200 are controlled in accordance with a predetermined manner when thetriggering system 400 is activated. Thereby, movement and/or positioningof the distal end regions 310 b, 320 b, 330 b, 340 b, and/or 210 b canbe initiated when at least a predetermined quantity of force is appliedto the switching system 450. Stated somewhat differently, a force thatis less than the predetermined quantity generally may be insufficient toactivate the triggering system 400; whereas, when the force increases toa level that is greater than or substantially equal to the predeterminedquantity, the triggering system 400 is configured to activate, moveand/or position the distal end regions 310 b, 320 b, 330 b, 340 b,and/or 210 b in accordance with the predetermined manner. The triggeringsystem 400, once activated, can continue to move and/or position thedistal end regions 310 b, 320 b, 330 b, 340 b, and/or 210 b inaccordance with the predetermined manner until the closure element 500is deployed.

The triggering system 400, for example, can include one or more sets ofcooperating detents for coupling the axial motion of the distal endregions 310 b, 320 b, 330 b, and 340 b in accordance with apredetermined manner when the triggering system 400 is activated. Theterm “detents” refers to any combination of mating elements, such asblocks, tabs, pockets, slots, ramps, locking pins, cantilevered members,support pins, and the like, that may be selectively or automaticallyengaged and/or disengaged to couple or decouple the carrier member 310,the pusher member 320, the cover member 330, and the support member 340relative to one another. It will be appreciated that the cooperatingdetents as illustrated and described below are merely exemplary and notexhaustive. For example, the cooperating detents can include a first setof cooperating blocks and pockets for releasably coupling the supportmember 340, the carrier member 310, the pusher member 320, and the covermember 330. When the carrier assembly 300 reaches a first predetermineddistal position, the support member 340 can be decoupled from thecarrier member 310, the pusher member 320, and the cover member 330 andcan be substantially inhibited from further axial movement. Thereby, thecarrier member 310, the pusher member 320, and the cover member 330 maycontinue to be directed distally as the support member 340 remainssubstantially stationary.

As shown in FIGS. 4B-4C, the cooperating detents can include a carrierblock 410, a pusher block 420, a cover block 430, and a support block440, which can be configured to couple and decouple in accordance withthe predetermined manner. For example, the carrier block 410 can bedisposed on the proximal end region 310 a of the carrier member 310 andcan include a carrier pin 412 c that extends from the carrier block 410;whereas, the proximal end region 330 a of the cover member 330 and theproximal end region 340 a the support member 340 are respectivelycoupled with the cover block 430 and the support block 440. A cover pin432 b can extend from the cover block 430, and the support block 440 canhave a support pin 442 a, which extends from the support block 440. Thesupport pin 442 a, the cover pin 432 b, and the carrier pin 412 c eachcan be formed from a substantially rigid material, such as an alloy ofnickel-titanium.

The pusher block 420 can be disposed on the proximal end region 320 a ofthe pusher member 320 and forms a support slot 422 a, a cover slot 422b, and a carrier slot 422 c. The support slot 422 a can be configured toreceive and releasably engage the support pin 442 a by which the supportmember 340 can be coupled with, and decoupled from, the pusher member320. The cover member 330 can be coupled with, and decoupled from, thepusher member 320 via the cover slot 422 b, which is configured toreceive and releasably engage the cover pin 432 b. The carrier slot 422c can be configured to receive and releasably engage the carrier pin 412c such that the carrier member 310 can be coupled with, and decoupledfrom, the pusher member 320. The carrier block 410, the pusher block420, the cover block 430, and the support block 440 can be respectivelydisposed substantially on the outer peripheries 312 b, 322 b, 332 b, and342 b and can be configured to couple and decouple in accordance withthe predetermined manner.

The triggering system 400 can further include one or more stops forengaging the pusher block 420, the cover block 430, and/or the supportblock 440, respectively. As illustrated in FIG. 4B, a support stop 460a, a cover stop 460 b, and a carrier stop 460 c each can be formed inthe housing 380 and are configured to receive, and substantially inhibitfurther movement of, the support block 440, the cover block 430, and thecarrier block 410, respectively, in accordance with the predeterminedmanner. For example, when an axial force is applied to the tube set 305via the switching system 450, the cover block 430 can move distallywithin the housing 380, and the cover block 430 approaches the coverstop 460 b. Upon being received by the cover stop 460 b, the cover block430 can be substantially locked in place, substantially preventing anyfurther motion of the cover block 430.

Resisting the axial force, the cover pin 432 b can provide a static loadwhile the axial force is less than the predetermined quantity of force.As the axial force increases to a level that is greater than orsubstantially equal to the predetermined quantity, the cover pin 432 bcan be displaced from the cover slot 422 b, decoupling the cover member330 from the carrier member 310, the pusher member 320, and the supportmember 340. Creating the internal resistance to be overcome by thetriggering system 400, the static forces provided by the pins 442 a, 432b, and 412 c is approximately proportional to a composition andcross-section of the respective pins 442 a, 432 b, and 412 c and/or adepth and a slope of the respective slots 422 a, 422 b, and 422 c. Asdesired, the pins 442 a, 432 b, and 412 c can be configured to providestatic loads that are differing and/or substantially uniform.

Turning to FIG. 4D, the triggering system 400 may further include a tuberelease system 470 for inhibiting inadvertent advancement of the tubeset 305. The tube release system 470 is coupled with a tube releasemember 480, such as a rod, wire, or other elongate member. The tuberelease member 480 has a proximal end region 480 a that is disposedsubstantially between the pusher block 420 and the housing 380 (shown inFIG. 4A) and a distal end region 480 b that is coupled with the tuberelease system 470. Optionally, a tab 485 is coupled with the proximalend region 480 a of the tube release member 480, and a pin (not shown)extends from the pusher block 420 and is disposed substantially betweenthe tab 485 and a groove (not shown) formed in the housing 380. The tuberelease system 470 is configured to release the tube set 305 when thetube release member 480 is moved proximally, freeing the pusher block420.

A locator release system 490 for permitting the distal end region 210 b,the expansion elements 230, and/or the substantially flexible members230′ of the locator assembly 200 to transition from the expanded stateto the unexpanded state can be included with the triggering system 400.The locator release system 490 can include a rod, wire, or otherelongate member and has a proximal end region 490 a and a distal endregion 490 b. The proximal end region 490 a of the locator releasesystem 490 can be coupled with, and configured to activate, the locatorcontrol system 240 (shown in FIG. 2D), and the distal end region 490 bextends beyond the pusher block 420. Thereby, when the pusher block 420is advanced during deployment of the closure element 500, the controlblock 260 can be disengaged such that the distal end region 210 b, theexpansion elements 230, and/or the substantially flexible members 230′of the locator assembly 200 to transition from the expanded state to theunexpanded state.

The operation of the triggering system 400 in accordance with onepredetermined manner is illustrated in FIGS. 5A-5C with the closureelement 500 (shown in FIGS. 6A-6B) disposed substantially within theapparatus 100. As shown in Figure SA, the distal end region 210 b of thelocator assembly 200 has been positioned as desired and has transitionedfrom the unexpanded state to the expanded state. While the locatorcontrol system 240 (shown in FIG. 2D) maintains the distal end region210 b in the expanded state, a distally-directed axial force can beapplied to the triggering system 400 via the switching system 450. Oncethe tube release member 480 (shown in FIG. 4D) has been moved proximallyto free the pusher block 420, the tube set 305 can be substantiallyfreely slidable within the housing 380 and responds to the axial forceby sliding distally from an initial predetermined position to a firstpredetermined position.

In the initial predetermined position, the carrier member 310, thepusher member 320, the cover member 330, and the support member 340 canbe coupled via the slots 422 c, 422 b, and 422 a (shown in FIG. 4C) andthe pins 412 c, 432 b, and 442 a (shown in FIG. 4C). Stated somewhatdifferently, the support pin 442 a, the cover pin 432 b, and the carrierpin 412 c can be respectively disposed within, and engaged by, thesupport slot 422 a, the cover slot 422 b, and the carrier slot 422 csuch that the carrier block 410, the pusher block 420, the cover block430, and the support block 440 are coupled as illustrated in FIG. 4C.Therefore, the carrier member 310, the pusher member 320, the covermember 330, and the support member 340 each can slide distally from theinitial predetermined position to the first predetermined position inresponse to the axial force.

FIG. 5B illustrates the positions of the carrier member 310, the pushermember 320, the cover member 330, and the support member 340 (FIG. 4C)upon reaching the first predetermined position. In the firstpredetermined position, the support block 440 and the cover block 430can respectively engage the support stop 460 a and the cover stop 460 b.Thereby, the support stop 460 a can receive, and substantially inhibitfurther movement of, the support block 440 and, therefore, the supportmember 340; whereas, the cover stop 460 b receives, and substantiallyinhibits further movement of, the cover block 430 and, therefore, thecover member 330. Although the support block 440 and the cover block 430can engage the support stop 460 a and the cover stop 460 b in the firstpredetermined position, it will be appreciated that the support block440 can engage the support stop 460 a and the cover block 430 can engagethe cover stop 460 b in different predetermined positions. In otherwords, the predetermined manner can include any number of predeterminedpositions, each predetermined position being associated with any numberof the blocks 410, 420, 430, and 440 engaging any number of relevantstops 460 a, 460 b, and 460 c.

To continue distally from the first predetermined position, the carriermember 310 and the pusher member 320 can be decoupled from the covermember 330 and the support member 340 by disengaging the support pin 442a and the cover pin 432 b from the support slot 422 a and the cover slot422 b, respectively. In the manner described in more detail above withreference to FIGS. 4B-4C, the support pin 442 a and the cover pin 432 beach resist the axial force. While the axial force is less than thecombined static force provided by the support pin 442 a and the coverpin 432 b, the carrier member 310 and the pusher member 320 remaincoupled with the cover member 330 and the support member 340. As theaxial force increases to a level that is greater than or substantiallyequal to the combined static force, the support pin 442 a and the coverpin 432 b are respectively displaced from the support slot 422 a and thecover slot 422 b, decoupling the carrier member 310 and the pushermember 320 from the cover member 330 and the support member 340.Thereby, the cover member 330 and the support member 340 can beinhibited from further distal movement and remain substantiallystationary; whereas, the carrier member 310 and the pusher member 320can proceed distally toward a second predetermined position.

The pusher member 320 and the carrier member 310 can continue distallyuntil the second predetermined position is reached as shown in FIG. 5C.In the second predetermined position, the carrier block 410 can engagethe carrier stop 460 c. Whereby, the carrier stop 460 c can receive, andsubstantially inhibit further movement of, the carrier block 410 and,therefore, the carrier member 310. To continue distally from the secondpredetermined position, the pusher member 320 can be decoupled from thecarrier member 310 by disengaging the carrier pin 412 c from the carrierslot 422 c. In the manner described in more detail above with referenceto FIGS. 4B-C, the carrier pin 412 c resists the axial force. While theaxial force is less than the static force provided by the carrier pin412 c, the pusher member 320 remains coupled with the carrier member310.

As the axial force increases to a level that is greater than orsubstantially equal to the static force, the carrier pin 412 c can bedisplaced from the carrier slot 422 c, decoupling the pusher member 320from the carrier member 310. Thereby, the carrier member 310 can beinhibited from further distal movement and remains substantiallystationary; whereas, the pusher member 320 proceeds distally to deploythe closure element 500 and to activate the locator release system 490(shown in FIG. 4D) such that the distal end region 210 b, the expansionelements 230, and/or the substantially flexible members 230′ of thelocator assembly 200 transition from the expanded state to theunexpanded state. The axial force that is applied to overcome the staticforce associated with the first predetermined position is sufficient toovercome the static forces associated with the subsequent predeterminedpositions, to deploy the closure element 500, and to activate thelocator release system 490 such that the triggering system 400 operatesin one substantially-continuous motion.

It will be appreciated that the triggering system 400 can include anenergy storing element (not shown), which can be disposed substantiallybetween the housing 380 and the blocks 410, 420, 430, and 440 and whichcan be configured to store potential energy for moving the tube set 305from the initial predetermined position through the other predeterminedpositions, deploying the closure element 500, and/or activating thelocator release system 490. The energy-storing element can be configuredstore the potential energy when the tube set 305 is in the initialpredetermined position and to release the potential energy, whenactivated, such that the tube set 305 travels through the predeterminedpositions at a substantially constant and continuous rate. For example,the energy-storing element can include one or more springs (not shown).Each of the springs can be in a compressed state when the tube set 305is in the initial predetermined position and released from thecompressed state when the switching system 450 of the triggering system400 is activated.

In use, the closure element 500 can be disposed within the carrierassembly and adjacent to the distal end of the pusher tube 320. As shownin FIGS. 7A-7B, for example, the reduced closure element 500′ can beslidably received over the distally-increasing cross-section 318 b ofthe distal end region 310 b of the carrier member 310 and disposed aboutthe periphery 312 of the carrier member 310 adjacent to the space 360.Since the reduced cross-section 530′ of the reduced closure element 500′is less than the cross-section 318 b of the distally-increasingcross-section 318 b, the reduced closure element 500′ must betemporarily radially deformed to be received over the distal end region310 b. Also, as the reduced closure element 500′ is received over thedistal end region 310 b, the opposing tines 520 of the reduced closureelement 500′ engages the distal end region 310 b. The reduced closureelement 500′ thereby can form the substantially tubular closure element500″ in the manner described in more detail above with reference toFIGS. 6E-6G.

After being received over the distal end region 310 b, the substantiallytubular closure element 500″ can be disposed about the space 360, andthe tines 520 are directed substantially distally as shown in FIG. 7B.As desired, one or more of the tines 520 can be disposed proximally ofthe distally-increasing cross-section 318 b of the distal end region 310b, as illustrated in FIG. 7B, and/or can be at least partially disposedupon, and contact, the distally-increasing cross-section 318 b of thedistal end region 310 b. To improve the engagement between the closureelement 500 (shown in FIGS. 6A-6B) and the blood vessel wall 620 and/ortissue 630 (collectively shown in FIG. 8A), the substantially tubularclosure element 500″ can be disposed on the carrier member 310 such thatthe tines 520 define a first plane that is substantially perpendicularto a second plane defined by the switching system 450 and/or the handles390 (collectively shown in FIG. 4D).

Once disposed about the space 360, the substantially tubular closureelement 500″ can be retained on the outer periphery 312 b of the carriermember 310 when distal end region 310 b of the carrier member 310 andthe distal end region 320 b of the pusher member 320 are slidablyreceived within the lumen 334 of the cover member 330 as illustrated inFIGS. 7C-7D. When the cover member 330 is properly positioned within thecarrier assembly 300, the distal end region 330 b of the cover member330 can extend over the space 360 and define the annular cavity 370 forretaining the substantially tubular closure element 500″. As such, thesubstantially tubular closure element 500″ is disposed substantiallybetween the outer periphery 312 b of the carrier member 310 and theinner periphery 332 a of the cover member 330 such that thesubstantially tubular closure element 500″ maintains the substantiallytubular configuration with the tines 520 being directed substantiallydistally. As desired, the cover member 330 may radially compress thesubstantially tubular closure element 500″ such that the substantiallytubular closure element 500″ enters and maintains a compressed tubularconfiguration. The body 510 of the substantially tubular closure element500″ can be disposed distally of the distal end region 320 b of thepusher member 320, as illustrated in FIGS. 7C-7D, or can engage thedistal end region 320 b, as desired.

Turning to FIG. 8A, a sheath 640 may be inserted or otherwise positionedthrough skin 650 and tissue 630 and within the blood vessel 600 or otherbody lumen via the opening 610. While including a substantially flexibleor semi-rigid tubular member, the sheath 640 can have a proximal endregion 640 a and a distal end region 640 b and includes a predeterminedlength and a predetermined cross-section, both of which can be of anysuitable dimension. The sheath 640 also can form a lumen 644 thatextends along a longitudinal axis of the sheath 640 and substantiallybetween the proximal and distal end regions 640 a, 640 b. The lumen 644can have any suitable internal cross-section 648 b and is suitable forreceiving one or more devices (not shown), such as a catheter, a guidewire, or the like. The lumen 644 can be configured to slidably receivethe tubular body 210 of the locator assembly 200 (shown in FIG. 4A)and/or the tube set 305 of the carrier assembly 300 (shown in FIG. 4A).

Since the internal cross-section 648 b of the sheath 640 typically canbe less than or substantially equal to the predetermined cross-section338 b of the cover member 330, the sheath 640 may be configured toradially expand, such as by stretching, to receive the tube set 305.Alternatively, or in addition, the sheath 640 can be advantageouslyconfigured to split as the tube set 305 is received by, and advanceswithin, the lumen 644 of the sheath 640, thereby permitting theapparatus 100 to access the blood vessel wall 620. To facilitate thesplitting, the sheath 640 can include one or more splits 645, such aslongitudinal splits, each split being provided in the manner known inthe art. Each split 645 can be configured to split the sheath 640 inaccordance with a predetermined pattern, such as in a spiral pattern. Itwill be appreciated that, when the internal cross-section 648 b of thesheath 640 is greater than the predetermined cross-section 338 b of thecover member 330, it may not be necessary for the sheath 640 to beconfigured to radially expand and/or split. In addition to, or as analternative to, the apparatus 100 may include a cutting means thatinitiates a tear line or split in the sheath when the sheath is engagedwith the distal end of the apparatus 100.

The sheath 640 may be advanced over a guide wire or other rail (notshown) which has been positioned through the opening 610 and into theblood vessel 600 using conventional procedures such as those describedabove. The blood vessel 600 is a peripheral blood vessel, such as afemoral or carotid artery, although other body lumens may be accessedusing the sheath 640 as will be appreciated by those skilled in the art.The opening 610, and consequently the sheath 640, may be oriented withrespect to the blood vessel 600 such as to facilitate the introductionof devices through the lumen 644 of the sheath 640 and into the bloodvessel 600 with minimal risk of damage to the blood vessel 600. One ormore devices (not shown), such as a catheter, a guide wire, or the like,may be inserted through the sheath 640 and advanced to a preselectedlocation within the patient's body. For example, the devices may be usedto perform a therapeutic or diagnostic procedure, such as angioplasty,atherectomy, stent implantation, and the like, within the patient'svasculature.

After the procedure is completed, the devices are removed from thesheath 640, and the apparatus 100 is prepared to be received by thelumen 644 of the sheath 640 as shown in FIG. 8B. Being in the unexpandedstate, the distal end region 210 b of the tubular body 210 of thelocator assembly 200 can be slidably received by the lumen 644 andatraumatically advanced distally into the blood vessel 600 asillustrated in FIGS. 8B-C. Once the distal end region 210 b of thetubular body 210 extends into the blood vessel 600, the distal endregion 210 b can transition from the unexpanded state to the expandedstate as shown in FIG. 8D by activating the switching system of thelocator assembly 200.

Turning to FIG. 8E, the apparatus 100 and the sheath 640 then can beretracted proximally until the distal end region 210 b is substantiallyadjacent to an inner surface 620 b of the blood vessel wall 620. Thedistal end region 210 b thereby can draw the blood vessel wall 620 tautand maintains the proper position of the apparatus 100 as the bloodvessel 600 pulsates. Since the expanded cross-section of the distal endregion 210 b can be greater than or substantially equal to thecross-section of the opening 610 and/or the cross-section of the lumen644, the distal end region 210 b remains in the blood vessel 600 andengages the inner surface 620 b of the blood vessel wall 620. The distalend region 210 b can frictionally engage the inner surface 620 b of theblood vessel wall 620, thereby securing the apparatus 100 to the bloodvessel 600. The sheath 640 can be retracted proximally such that thedistal end region 640 b of the sheath 640 is substantially withdrawnfrom the blood vessel 600, as shown in FIG. 8E, permitting the apparatus100 to access the blood vessel wall 620.

As the apparatus 100 is being retracted, the apparatus 100 can beaxially rotated such that the first plane defined by the tines 520 ofthe substantially tubular closure element 500″ is substantially parallelwith a third plane defined by the blood vessel 600. Thereby, theengagement between the substantially tubular closure element 500″ andthe blood vessel wall 620 and/or tissue 630 can be improved because thetines 520 are configured to engage the blood vessel wall 620 and/ortissue 630 at opposite sides of the opening 610. If the substantiallytubular closure element 500″ is disposed on the carrier member 310 suchthat the first plane defined by the tines 520 is substantiallyperpendicular to the second plane defined by the switching system 450and/or the handles 390 (collectively shown in FIG. 5A), for example, theapparatus 100 can be positioned such that the second plane defined bythe switching system 450 and/or the handles 390 is substantiallyperpendicular to the third plane defined by the blood vessel 600.

Once the distal end region 210 b of the locator assembly 200 contactsthe inner surface 620 b of the blood vessel wall 620, the tube set 305can then be advanced distally and received within the lumen 644 of thesheath 640 as illustrated in FIG. 8F. In the manner described in moredetail above with reference to FIG. 8A, the sheath 640 can radiallyexpand and/or split in accordance with the predetermined pattern as thetube set 305 advances because the internal cross-section 648 b of thesheath 640 is less than or substantially equal to the predeterminedcross-section 338 b of the cover member 330. Being coupled, the carriermember 310, the pusher member 320, the cover member 330, and the supportmember 340 each advance distally and approach the first predeterminedposition as illustrated in FIG. 8G.

Upon reaching the first predetermined position, the tube set 305 can bedisposed substantially adjacent to the outer surface 620 a of the bloodvessel wall 620 adjacent to the opening 610 such that the blood vesselwall 620 adjacent to the opening 610 is disposed substantially betweenthe expanded distal region 210 b of the locator assembly 200 and thetube set 305. The cover member 330 and the support member 340 can eachdecouple from the carrier member 310 and the pusher member 320 in themanner described in more detail above with reference to FIGS. 5A-5C whenthe tube set 305 is in the first predetermined position. Thereby, thecover member 330 and the support member 340 can be inhibited fromfurther axial movement and remain substantially stationary as thecarrier member 310 and the pusher member 320 each remain coupled andaxially slidable.

As shown in FIG. 8H, the cover member 330 and the support member 340 canremain substantially stationary while the carrier member 310 and thepusher member 320 can continue distally and approach the secondpredetermined position. As the carrier member 310 and the pusher member320 distally advance toward the second predetermined position, theannular cavity 370 can move distally relative to thesubstantially-stationary cover member 330 such that the distal endregion 330 b of the cover member 330 no longer encloses the annularcavity 370.

Thereby, the substantially tubular closure element 500″ may not becompletely enclosed by the annular cavity 370 formed by the distal endregions 310 b, 320 b, and 330 b of the carrier member 310, the pushermember 320, and the cover member 330.

Although not completely enclosed by the annular cavity 370, thesubstantially tubular closure element 500″ can be advantageouslyretained on the outer periphery 312 b of the carrier member 310 by thedistal end region 330 b of the cover member 330 as illustrated in FIG.8H. For example, by retaining the substantially tubular closure element500″ between the distal end region 330 b of the cover member 330 and thedistal end region 310 b the carrier member 310, the apparatus 100 can beconfigured to provide better tissue penetration. The timing between thedeployment of the substantially tubular closure element 500″ by the tubeset 305 and the retraction and transition to the unexpanded state by thelocator assembly 200 likewise is facilitated because the substantiallytubular closure element 500″ is retained between the distal end region330 b and the distal end region 310 b. Further, the carrier member 310and the cover member 330 can operate to maintain the substantiallytubular closure element 500″ in the tubular configuration.

When the tube set 305 is in the second predetermined position, thecarrier member 310 can decouple from the pusher member 320 in the mannerdescribed in more detail above with reference to FIGS. 5A-5C. Therefore,the carrier member 310, the cover member 330, and the support member 340can be inhibited from further axial movement and remain substantiallystationary; whereas, the pusher member 320 remains axially slidable. Asthe pusher member 320 continues distally, the distal end region 320 b ofthe pusher member 320 can contact the substantially tubular closureelement 500″ and displaces the substantially tubular closure element500″ from the space 360 as shown in FIG. 8I. Since the space 360 issubstantially radially exposed, the pusher member 320 can direct thesubstantially tubular closure element 500″ over the distally-increasingcross-section of the distal end region 310 b of thesubstantially-stationary carrier member 310 such that the cross-section530′ (shown in FIGS. 6F-6G) of the substantially tubular closure element500″ begins to radially expand in a substantially uniform manner. As thesubstantially tubular closure element 500″ traverses thedistally-increasing cross-section of the distal end region 310 b, thecross-section 530′ of the substantially tubular closure element 500″radially expands beyond the natural cross-section 530 (shown in FIGS.6A-6B) of the closure element 500.

Upon being directed over the distally-increasing cross-section of thedistal end region 310 b by the pusher member 320, the substantiallytubular closure element 500″ can be distally deployed as illustrated inFIG. 8J. When the substantially tubular closure element 500″ isdeployed, the tines 520 can pierce and otherwise engage a significantamount of the blood vessel wall 620 and/or tissue 630 adjacent to theopening 610. For example, the tines 520 can engage a significant amountof the blood vessel wall 620 and/or tissue 630 because the cross-section530′ of the substantially tubular closure element 500″ is expandedbeyond the natural cross-section 530 of the closure element 500 duringdeployment.

As the closure element is being deployed from the space 360, the locatorassembly 200 can also begin to retract proximally and the locatorrelease system 490 (shown in FIG. 4D) can be activated to transitionfrom the expanded state to the unexpanded state as the substantiallytubular closure element 500″ is deployed as shown in FIG. 8J. The distalend region 210 b of the locator assembly 200 retracts proximally andtransitions from the expanded state to the unexpanded statesubstantially simultaneously with the deployment of the substantiallytubular closure element 500″. As desired, the distal end region 210 bmay be configured to draw the blood vessel wall 620 and/or tissue 630adjacent to the opening 610 proximally and into the channel 540 definedby the substantially tubular closure element 500″. The tines 520 of thesubstantially tubular closure element 500″ thereby can pierce andotherwise engage the drawn blood vessel wall 620 and/or tissue 630.Since the cross-section 530′ of the substantially tubular closureelement 500″ is expanded beyond the natural cross-section 530 of theclosure element 500, a significant amount of the blood vessel wall 620and/or tissue 630 can be drawn into the channel 540 and engaged by thetines 520.

Turning to FIG. 8K, the substantially tubular closure element 500′, oncedeployed, can begin to transition from the tubular configuration,returning to the natural, planar configuration with opposing tines 520and a natural cross-section 530 of the closure element 500. Thesubstantially tubular closure element 500′ substantially uniformlytransitions from the tubular configuration to the natural, planarconfiguration. Rotating axially inwardly to form the opposing tines 520of the closure element 500, the tines 520 draw the tissue 630 into thechannel 540 as the substantially tubular closure element 500″ forms theclosure element 500. Also, the tissue 630 can be drawn substantiallyclosed and/or sealed as the cross-section 530′ of the substantiallytubular closure element 500′ contracts to return to the naturalcross-section 530 of the closure element 500. Thereby, the opening 610in the blood vessel wall 620 can be drawn substantially closed and/orsealed via the closure element 500 as illustrated in FIG. 8L.

It will be appreciated that the closure element 500 may be constructedof other materials, that it may include alternative shapes, and that itmay adopt alternative methods of operation such that the closure element500 achieves closure of openings in blood vessel walls or other bodytissue. In an additional non-limiting example, the closure element 500is constructed of materials that use a magnetic force to couple a pairof securing elements in order to close an opening in the lumen wall ortissue. In this alternative embodiment, the closure element 500 may beof a unitary or multi-component construction having a first securingelement positionable at a first position adjacent the opening, and asecond securing element positionable at a second position adjacent theopening. The first and second securing elements can be provided having amagnetic force biasing the first and second securing elements together,thereby closing the opening, or they are provided having a magneticforce biasing both the first and second securing elements toward a thirdsecuring element positioned in a manner to cause closure of the opening.The magnetic closure element 500 may be provided without tines 520,provided the magnetic force coupling the closure elements is sufficientto close the opening. Alternatively, the closure element 500 may beprovided with a combination of the magnetic securing elements and tines520 to provide a combination of coupling forces. Those skilled in theart will recognize that other and further materials, methods, andcombinations may be utilized to construct the closure element 500 toachieve the objectives described and implied herein.

It will be appreciated that the distal end region 380 b of the housing380 can be configured to couple with an introducer sheath 700 as shownin FIG. 9. While being prepared from a substantially flexible orsemi-rigid tubular member, the introducer sheath 700 can have a proximalend region 700 a and a distal end region 700 b and includes apredetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension. The distal end region 700 b can beconfigured to facilitate insertion of the introducer sheath 700 throughtissue and/or into the opening 610 (shown in FIG. 8A) formed in and/oradjacent to the wall 620 (shown in FIG. 8A) of the blood vessel 600(shown in FIG. 8A) or other body lumen. For example, the distal endregion 430 b can have a tapered tip (not shown) for facilitatingsubstantially atraumatic introduction of the introducer sheath 700through a passage formed in the tissue 630 and/or at least partiallyinto the blood vessel wall 620, which is accessible via the passage.

The introducer sheath 700 can also form a lumen 704 that extends along alongitudinal axis of the introducer sheath 700 and substantially betweenthe proximal and distal end regions 700 a, 700 b. The lumen 704 can haveany suitable length 708 a and internal cross-section 708 b and isconfigured to slidably receive the tubular body 210 of the locatorassembly 200 (shown in FIG. 4A) and/or the tube set 305 of the carrierassembly 300 (shown in FIG. 4A). Since the internal cross-section 708 bof the introducer sheath 700 typically can be less than or substantiallyequal to the predetermined cross-section 338 b of the cover member 330,the introducer sheath 700 may be configured to radially expand, such asby stretching, to receive the tube set 305. Alternatively, or inaddition, the introducer sheath 700 can be advantageously configured tosplit as the tube set 305 is received by, and advances within, the lumen704 of the introducer sheath 700 in the manner described in more detailabove with reference to the sheath 640 (shown in FIG. 8A). To facilitatethe splitting, the introducer sheath 700 can include one or more splits(not shown), such as longitudinal splits, each split being provided inthe manner known in the art. Each split is configured to split theintroducer sheath 700 in accordance with a predetermined pattern, suchas in a spiral pattern. It will be appreciated that, when the internalcross-section 708 b of the introducer sheath 700 is greater than thepredetermined cross-section 338 b of the cover member 330, it may not benecessary for the introducer sheath 700 to be configured to radiallyexpand and/or split.

The introducer sheath 700 can be coupled with the housing 380 via one ormore cooperating connectors (not shown) such that the lumen 704 issubstantially axially aligned with the tubular body 210 of the locatorassembly 200 and/or the tube set 305 of the carrier assembly 300 and, asdesired, may be removably and/or substantially permanently coupled withthe housing 380. For example, a hub assembly 710 can be coupled with theproximal end region 700 a of the introducer sheath 700. The proximal endregion 700 a of the introducer sheath 700 can be coupled with, orotherwise provided on, a distal end region 710 b of the hub assembly710, such as via an adhesive, one or more cooperating connectors, and/ora thermo-mechanical joint.

The hub assembly 710 can also include a proximal end region 710 a, whichprovides the one or more mating connectors for coupling the introducersheath 700 with the housing 380 and forms a lumen (not shown), whichextends substantially between the proximal end region 710 a and thedistal end region 710 b. The lumen of the hub assembly 710 can have aninternal cross-section or size that is greater than the internalcross-section or size of the lumen 704 of the introducer sheath 700.When the proximal end region 700 a of the introducer sheath 700 isproperly connected with the hub assembly 710, the lumen of the hubassembly 710 can be configured to communicate with the lumen 704 of theintroducer sheath 700. As desired, the proximal end region 700 a of theintroducer sheath 700 may be flared to facilitate the connection betweenthe introducer sheath 700 and the hub assembly 710.

When properly assembled, the hub assembly 710 can be substantially fluidtight such that the one or more devices can be inserted into the lumen704 of the introducer sheath 700 without fluid passing proximallythrough the lumen 704. The hub assembly 710 can be made to bewatertight, such as via one or more seals (not shown) and/or valves (notshown) in the manner known in the art. For example, the hub assembly 710can include a thrust washer and/or valve, a guide for directing thedevices into the lumen 704 of the introducer sheath 700, and/or a seal(collectively not shown). The various seals and/or guides can be coupledwith the hub assembly 710 via, for example, one or more spacers and/orend caps (also collectively not shown).

As desired, the hub assembly 710 further can include one or more sideports 720. The side ports 720 can communicate with the lumen of the hubassembly 710 and/or the lumen 704 of the introducer sheath 700. At leastone of the side ports 720 can be configured to be connected with, and tocommunicate with, tubing (not shown) to, for example, infuse fluids intothe lumen 704 and through the introducer sheath 700. Alternatively, orin addition, at least one of the side ports 720 can provide a “bleedback” indicator, such as in the manner disclosed in the co-pendingapplication Ser. No. 09/680,837. The disclosures of this reference andany others cited therein are expressly incorporated herein by reference.

Another alternative embodiment of a clip applier for sealing openingsthrough tissue is shown in FIGS. 10-15. The embodiment of FIGS. 10-15,as described below, has many identical or similar structures thatperform identical or similar functions to the embodiments describedabove and in reference to the preceding Figures. Accordingly, thedescription below should be considered in view of the descriptions aboveof the preceding embodiments. Furthermore, those of ordinary skill inthe art will appreciate that one or more of the components and/orfeatures of the embodiment shown in FIGS. 10-15 may also be incorporatedin the previously described embodiments, as those components and/orfeatures of the previously described embodiments may optionally beincorporated in the embodiment described below and in reference to FIGS.10-15. In the description of the alternative embodiment below, and inFIGS. 10-15, components of the apparatus that are identical orsubstantially correspond to those previously described will bear thesame reference numerals identified above with the addition of the prime(′) identifier.

Turning to FIGS. 10 and 11, the locator assembly 200′ can besubstantially similar to the structure described above in reference toFIGS. 2A-2D, including a flexible or semi-rigid tubular body 210′ (suchas an elongate rail) with a longitudinal axis. The tubular body 210′ canhave a proximal end region 210 a′ and a distal end region 210 b′ andincludes a predetermined length 218 a′ and a predetermined outercross-section, both of which can be of any suitable dimension. Thedistal end region 210 b′ of the locator assembly 200′ can include asubstantially rounded, soft, and/or flexible distal end or tip 220′ tofacilitate atraumatic advancement and/or retraction of the distal endregion 210 b′ into the blood vessel 600. As desired, a pigtail (notshown) may be provided on the distal end 220′ to further aid atraumaticadvancement of the distal end region 210 b′.

The distal end region 210 b′ of the locator assembly 200′ can beselectably controllable between an unexpanded state and an expandedstate, in the manner described above in relation to FIGS. 2A-2D. In thealternative embodiment shown in FIGS. 10A-10B, the distal end region isshown in its expanded state, wherein the substantially flexible members230′ of the expansion elements 230 are flexed outward.

A control member 250′, such as a rod, wire, or other elongate member,can be moveably disposed within a lumen (not shown) formed by thetubular body 210′ and extending substantially between the proximal endregion 210 a′ and the distal end region 210 b′. The control member 250′can have a proximal end region 250 a′ that is coupled with a controlblock 260′, and a distal end region that is coupled with the distal endregion 210 b′ of the locator assembly 200′, the expansion elements 230,and/or the movable end regions 230 c′ of the substantially flexiblemembers 230′. The control block 260′ can be a tubular shape and formedof a metal or rigid plastic, and is adapted to be retained in a controlblock cavity 265′ (see FIG. 10B) formed on the internal surface of thehousing bottom half 380 d′, to thereby maintain the control block 260′in a substantially fixed position relative to the housing 380′. Thelocator control system can selectively transition the distal end region210 b′, the expansion elements 230, and/or the substantially flexiblemembers 230′ between the unexpanded and expanded states by moving thetubular body 210′ axially relative to the control member 250′.

Formed on the proximal end 210 a′ of the tubular body 210′ can have atubular body block 270′ having a proximal groove 271′. The tubular bodyblock 270′ can be formed of metal, rigid plastic, or other substantiallyrigid material and can be formed integrally with or attached securely tothe tubular body 210′. The proximal groove 271′ and the proximal end ofthe tubular body block 270′ can have a shape adapted to cooperate with apair of tabs 281 a′-b′ formed on a locator assembly block 280′ wherebythe tubular body block 270′ is maintained in a fixed axial relationshipwith the locator assembly block 280′. In this way, the tubular bodyblock 270′ and tubular body 210′ can be advanced distally by distaladvancement of the locator assembly block 280′.

A locator assembly spring 290′ can be located coaxially with andsubstantially surrounds a portion of the tubular body block 270′. Thelocator assembly spring 290′ can be located between and contacts thedistal side of two of the tabs 281 a′-b′ formed on the locator assemblyblock 280′, and the proximal side of a locator assembly spring stop 381′formed on the inner surface of the housing bottom half 380 d′ (see FIG.10B). The locator assembly spring 290′ so located can provide a forcebiasing the locator assembly block 280′ in the proximal directionrelative to the housing 380′.

The locator assembly block 280′ can be formed of metal, plastic, orother rigid material. A function of the locator assembly block 280′ canallow the user to apply a force causing distal movement of the tubularbody 210′ relative to the control member 250′ to cause the locatorassembly 200′ to transition from the unexpanded state to the expandedstate. The proximal end of the locator assembly block 280′ can have aslot 281′ formed therein, the slot 281′ can have a size sufficient toaccommodate the control block 260′ and the control block cavity 265′,and to allow the locator assembly block 280′ to travel axially relativeto the housing 380′. The distal end of the locator assembly block 280′can have a pair of distally extending forks 282 a-b, with each of theforks 282 a-b having a ramp 283 a-b on its inward facing surface.Finally, the locator assembly block 280′ can have a pair of distallyextending release tabs 284 a-b, with each of the release tabs 284 a-bhaving a detent 285 a-b.

As shown in FIGS. 11A-11B, the locator assembly block 280′ can beslidably received and retained within grooves formed in the proximal endof the housing 380′, with the proximal end of the locator assembly blockextending from the proximal end of the housing. The control block 260′and control block cavity 265′ can be located in the slot 281′ formed inthe proximal end of the locator assembly block 280′.

The locator release system 490′ can perform the function of releasingthe locator assembly 200′, thereby allowing the locator assembly 200′ totransition from its expanded state to its unexpanded state. Turning toFIGS. 10A-10B and FIG. 15, the locator release system 490′ of thealternative embodiment of the apparatus can include locator release rod491′ having a release tab spacer block 492′ formed on its proximal end.The locator release rod 491′ and release tab spacer block 492′ can bereceived and retained in a groove formed on the interior surface of thehousing bottom half 380 d′. The release tab spacer block 492′ can beintegrally formed with or attached to the proximal end of the locatorrelease rod 491′, and is formed of metal, plastic, or other rigidmaterial. As shown in FIG. 15, the release tab spacer block 492′ canhave a shape and size adapted to fit between the release tabs 284 a-bformed on the locator assembly block 280′, thereby biasing the releasetabs 284 a-b outward and causing the outward facing detents 285 a-b toengage a pair of retaining grooves 286 a-b formed on the interior of thehousing 380′. As long as the detents 285 a-b are thus engaged with theretaining grooves 286 a-b of the housing 380′, the locator assemblyblock 280′ can be held in its axial position against the spring forceimparted in the proximal direction by the locator assembly spring 290′.The distal end of the locator release rod 491′ can have an engagementmember 493′ that includes an inward bend on the distal end of thelocator release rod. As described more fully below, the engagementmember 493′ on the locator release rod 491′ can be positioned within theapparatus such that, when the closure element 500 is delivered, theengagement member 493′ is engaged and caused to move axially in thedistal direction, thereby disengaging the release tab spacer block 492′from the locator assembly block 280′ and causing the locator assemblysimultaneously to transition from its expanded state to the unexpandedstate.

The alternative embodiment of the apparatus 100′ can include a carrierassembly 300′ that is coupled with, and slidable relative to, thelocator assembly 200′. The carrier assembly 300′ can be configured toreceive and retain the closure element 500 (shown in FIGS. 6A-6B), whichcan be disposed substantially within the carrier assembly 300′. When thelocator assembly 200′ engages the inner surface 620 b (shown in FIG. 8A)of the blood vessel wall 620 (shown in FIG. 8A), the carrier assembly300′ can be further configured to position the closure element 500substantially adjacent to the opening 610 and to deploy the closureelement 500, as described elsewhere herein.

Turning to FIGS. 10A-10B, the carrier assembly 300′ can include a tubeset having a carrier member 310′, a pusher member 320′, a cover member330′, and a support member 340′. The carrier member 310′, pusher member320′, cover member 330′, and support member 340′ can be provided as aplurality of nested, telescoping members with a common longitudinalaxis. The carrier member 310′ can be configured to receive and supportthe closure element 500. While being disposed on the carrier member310′, the closure element 500 can be deformed from the natural, planarconfiguration to form the substantially tubular closure element 500″(shown in FIGS. 6F-6G) as described herein.

The carrier member 310′ can include a proximal end region 310 a′ and adistal end region 310 b′. The carrier member 310′ can also define alumen 314′ that extends substantially between the proximal end region310 a′ and the distal end region 310 b′ and that is configured toslidably receive at least a portion of the tubular body 210′ of thelocator assembly 200′ and/or the support member 340′. Although theexterior cross-section of the carrier member 310′ is substantiallyuniform, the distal end region 310 b′ of the carrier member 310′ canhave a cross-section that increases distally, as illustrated in FIGS.10A-B, for substantially uniformly expanding the substantially tubularclosure element 500″ beyond the natural cross-section 530 of the closureelement 500 when the substantially tubular closure element 500″ isdeployed. Alternatively, the distal end region 310 b′ may be formed witha uniform cross-section to deploy the closure element 500 withoutcross-sectional expansion.

The pusher member 320′ can have a proximal end region 320 a′ and adistal end region 320 b′ and is coupled with, and slidable relative to,the carrier member 310′. The pusher member 320′ can include apredetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension and can be configured to slidablyreceive the carrier member 310′ such that the distal end region 320 b′of the pusher member 320′ is offset proximally from the distal endregion 310 b′ of the carrier member 310′. As desired, the predeterminedlength of the pusher member 320′ can be greater than or substantiallyequal to the predetermined length of the carrier member 310′. Thepredetermined length of the pusher member 320′ can be less than thepredetermined length of the carrier member 310′ such that the carriermember 310′ and the pusher member 320′ at least partially define a space360′ distal to the distal end region 320 b′ of the pusher member 320′and along the periphery of the carrier member 310′.

The pusher member 320′ can be substantially tubular and can define alumen (not shown) that extends substantially between the proximal endregion 320 a′ and the distal end region 320 b′ and that is configured toslidably receive at least a portion of the carrier member 310′. Thecross-section of the pusher member 320′ can be substantially uniform,and the distal end region 320 b′ of the pusher member 320′ can includeone or more longitudinal extensions 325′, which extend distally from thepusher member 320′ and along the periphery of the carrier member 310′.The longitudinal extensions 325′ can be biased such that thelongitudinal extensions 325′ extend generally in parallel with thecommon longitudinal axis of the carrier assembly tube set. Thelongitudinal extensions 325′ can be sufficiently flexible to expandradially, and yet sufficiently rigid to inhibit buckling, as the distalend region 320 b′ is directed distally along the carrier member 310′ andengage the distally-increasing cross-section of the distal end region310 b′ of the carrier member 310′ to deploy the substantially tubularclosure element 500″.

The cover member 330′ can be configured to retain the substantiallytubular closure element 500″ substantially within the carrier assembly300′ prior to deployment. Being coupled with, and slidable relative to,the pusher member 320′, the cover member 330′ can have a proximal endregion 330 a′ and a distal end region 330 b′ and includes apredetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension. The cover member 330′ can be formed asa substantially rigid, semi-rigid, or flexible tubular member.Additionally, the cover member 330′ can have an inner periphery and anouter periphery and can define a lumen (not shown). The lumen (notshown) can extend substantially between the proximal and distal endregions 330 a′, 330 b′ of the cover member 330′ and can be configured toslidably receive at least a portion of the pusher member 320′. When thecover member 330′ is properly positioned within the carrier assembly300′, the distal end region 330 b′ can be configured to extend over thespace 360′, thereby defining an annular cavity (not shown) for receivingand retaining the substantially tubular closure element 500″.

The cross-section of the cover member 330′ can be substantially uniform,and the distal end region 330 b′ of the cover member 330′ can includeone or more longitudinal extensions 335′, which extend distally from thecover member 330′ and along an outer periphery of the pusher member 320′(see FIG. 3D). Although the longitudinal extensions 335′ can extendgenerally in parallel with common longitudinal axis 350′, thelongitudinal extensions 335′ can be biased such that the plurality oflongitudinal extensions 335′ extend substantially radially inwardly asillustrated in FIGS. 3A and 3D. Thereby, the longitudinal extensions335′ can at least partially close the lumen (not shown) substantiallyadjacent to the distal end region 330 b′ of the cover member 330′. Topermit the substantially tubular closure element 500″ to be deployedfrom the annular cavity (not shown), the longitudinal extensions 335′can be sufficiently flexible to expand radially to permit the distal endregion 310 b′ of the carrier member 310′ to move distally past the covermember 330′ to open the annular cavity (not shown) such that the distalend region 330 b′ no longer extends over the space 360′.

If the carrier assembly 300′ is assembled as the plurality of nested,telescoping members as shown in FIG. 3A, the carrier member 310′ can beat least partially disposed within, and slidable relative to, the lumen(not shown) of the pusher member 320′. The support member 340′ can beslidable relative to the pusher member 320′. The pusher member 320′, inturn, can be at least partially disposed within, and slidable relativeto, the lumen (not shown) of the cover member 330′. To couple thecarrier assembly 300′ with the locator assembly 200′, the tubular body210′ of the locator assembly 200′ can be at least partially disposedwithin, and slidable relative to, the lumen 314′ of the carrier member310′. The longitudinal axis of the locator assembly 200′ can besubstantially in axial alignment with the common longitudinal axis ofthe carrier member 310′, the pusher member 320′, and the cover member330′.

The tube set 305 can also include a support member 340′ as shown inFIGS. 10A-B. The support member 340′ can be configured to slidablyreceive the tubular body 210′ of the locator assembly 200′ and toprovide radial support for the distal end region 210 b′ of the tubularbody 210′ when the locator assembly 200′ is coupled with the carrierassembly 300′. The carrier assembly 300′ can advantageously include thesupport member 340′, for example, if the tubular body 210′ is notsufficiently rigid or under other circumstances in which support for thetubular body 210′ might be desirable. It also will be appreciated thatthe support member 340′ also can be configured to inhibit the pluralityof longitudinal extensions 335′, which extend from the distal end region330 b′ of the cover member 330′, from expanding prematurely when theclosure element 500 is deployed. If the longitudinal extensions 335′were to expand prematurely, they may become hung up on the introducersheath 640 or other delivery member (in an introducer sheath or deliverymember is used), the tissue 630, or the wall 620 of the blood vessel600. This may interfere with the proper advancement or other movement ofthe cover member 330′ and the carrier assembly 300′.

The support member 340′ can be formed as a substantially rigid,semi-rigid, or flexible tubular member. Additionally, the support member340′ can include a proximal end region 340 a′ and a distal end region340 b′. Having an outer periphery, the support member 340′ can define alumen 344′ that extends substantially between the proximal end region340 a′ and the distal end region 340 b′ and that is configured toslidably receive and support at least a portion of the tubular body 210′of the locator assembly 200′. The support member 340′, in turn, can beat least partially slidably disposed within the lumen 314′ of thecarrier member 310′ such that the tubular body 210′ of the locatorassembly 200′ is coupled with, and slidable relative to, the carriermember 310′ in the manner described in more detail above. The supportmember 340′ can have a predetermined length and a predeterminedcross-section, both of which can be of any suitable dimension, and thecross-section can be substantially uniform. Although shown and describedas being substantially separate for purposes of illustration, it will beappreciated that the carrier member 310′, the pusher member 320′, thecover member 330′, and/or the support member 340′ can be provided, inwhole or in part, as one or more integrated assemblies.

The carrier assembly 300′ also can include a housing 380′, the top half380 c′ of which is illustrated in FIG. 10A, and the bottom half 380 d′of which is shown in FIG. 10B. The housing 380′ can be formed as anelongate member with a longitudinal axis. Additionally, the housing 380′can have an outer periphery and includes a proximal end region 380 a′and a distal end region 380 b′. Thereby, when the apparatus 100′ isproperly assembled, the tubular body 210′ of the locator assembly 200′can be at least partially disposed within, and slidable relative to, thetube set 305 such that the distal end region 210 b′ of the tubular body210′ extends beyond the distal end regions 310 b′, 320 b′, 330 b′,and/or 340 b′. The tubular body 210′, the carrier member 310′, thepusher member 320′, the cover member 330′, and, if provided, the supportmember 340′ can be at least partially disposed within, and slidablerelative to, the housing 380′, and the respective distal end regions 210b′, 310 b′, 320 b′, 330 b′, and 340 b′ extend from the distal end region380 b′ of the housing 380′ such that the common longitudinal axis 350′of the tube set 305 is substantially axially aligned with thelongitudinal axis 386′ of the housing 380′. Being configured to slidablyretain the respective proximal end regions 210 a′, 310 a′, 320 a′, 330a′, and 340 a′, the housing 380′ can support the tube set 305 and canhave one or more handles 391′, 392′ to facilitate use of the apparatus100′. The handles 391′, 392′ can extend substantially radially from theouter periphery of the housing 380′ and can be provided in the mannerknown in the art.

When the apparatus 100′ is properly assembled, the tubular body 210′ ofthe locator assembly 200′ can be at least partially disposed within, andslidable relative to, the tube set 305 of the carrier assembly 300′ suchthat the distal end region 210 b′ of the tubular body 210′ extendsbeyond the distal end regions 310 b′, 320 b′, 330 b′, and/or 340 b′.Further, the proximal end region 210 a′ of the tubular body 210′ and theproximal end regions 310 a′, 320 a′, 330 a′, and/or 340 a′ of the tubeset 305 can be at least partially disposed within, and slidable relativeto, the housing 380′. The switching system of the locator assembly 200′and a switching system of the triggering system 400′ can be accessibleexternal to the housing 380′ as shown in FIGS. 11-15.

As shown in FIGS. 11-15, the triggering system 400′ of the alternativeembodiment of the apparatus 100′ can be disposed substantially withinthe housing 380′. The triggering system 400′ can be configured tocontrol the relative axial movement and/or positioning of the respectivedistal end regions 310 b′, 320 b′, 330 b′, and 340 b′ of the tube set305 and/or the distal end region 210 b′ of the locator assembly 200′.Axial motion of one or more of the carrier member 310′, the pushermember 320′, the cover member 330′, and the support member 340′ and/orthe tubular body 210′ can be attained, for example, by applying an axialforce to the switching system 405′.

The triggering system 400′ can include a set of block members—a carrierblock 410′, a pusher block 420′, a cover block 430′, and a support block440′ —each of which is formed integrally with or securely attached toits respective member of the carrier assembly 300′. The block memberscan be adapted to selectably couple and decouple the carrier member310′, the pusher member 320′, the cover member 330′, and the supportmember 340′ relative to one another in order to provide axial movementof those components in a predetermined manner intended to deliver theclosure element 500 in the manner described herein. For example, whenthe carrier assembly 300′ reaches a first predetermined distal position,the support member 340′ can be decoupled from the carrier member 310′,the pusher member 320′, and the cover member 330′ and is thereaftersubstantially inhibited from further axial movement. Thereby, thecarrier member 310′, the pusher member 320′, and the cover member 330′may be directed distally as the support member 340′ remainssubstantially stationary. Subsequently, the carrier member 310′ and thecover member 330′ can be decoupled from the pusher member 320′ andthereafter inhibited from further axial movement. Thereby, the pushermember 320′ may be directed distally as the support member 340′, carriermember 310′, and cover member 330′ remain substantially stationary, asdescribed more fully herein.

The carrier block 410′ can be disposed on the proximal end region 310 a′of the carrier member 310′ and can include a trigger extension 405′ thatextends through a slot in the housing 380′ to the exterior of thehousing 380′ to be accessible to the user. The carrier block 410′ caninclude a pair of grooves 413 a-b formed on a peripheral surface of thecarrier block 410′, the grooves 413 a-b being adapted to receive andretain a pair of tabs 445 a-b formed on a pair of forks 444 a-bextending distally from the support block 440′, thereby selectablycoupling the support block 440′ to the carrier block 410′. The carrierblock 410′ can also include a pair of distal tabs 416 a-b extending fromthe distal end of the carrier block 410′, and adapted to engage a pairof slots 423 a-b formed on the proximal end of the pusher block 420′.

The carrier block 410′ can also include a pair of forks 414 a-bextending in the proximal direction from the proximal end of the carrierblock, each of the forks having an outward directed tab 415 a-b at itsproximal end. The tabs 415 a-b can be adapted to selectably engage apair of slots 387 a-b (not shown) formed on the interior surface of thehousing 380′ near its proximal end and, when so engaged, to fix theaxial position of the carrier block 410′ and, with it, the carrierassembly 300′ relative to the housing 380′. The tabs 415 a-b can bedisengaged from the slots in the housing when the locator assembly block280′ is moved axially in the distal direction in the following manner(see FIG. 11B). As the locator assembly block 280′ is advanced distally,the interior surfaces of the ramps 283 a-b on the locator assembly blockforks 282 a-b can engage the exterior surfaces of the tabs 415 a-b andcause the carrier block forks 414 a-b to flex inward, releasing the tabs415 a-b from the slots in the housing, thereby freeing the carrier block410′ and the carrier assembly 300′ to move axially. Thus, axial movementof the carrier block 410′ within the apparatus can be inhibited untilthe locator assembly block 280′ is advanced to transition the locatorassembly 200′ to the expanded condition, simultaneously releasing thetabs 415 a-b on the carrier block 410′.

The pusher block 420′ can be disposed on the proximal end region 320 a′of the pusher member 320′. As described above, the pusher block 420′ caninclude a pair of slots 423 a-b formed on its proximal end that areadapted to selectably engage the pair of distal tabs 416 a-b extendingfrom the distal end of the carrier block 410′. The pusher block 420′ canalso include a pair of grooves 424 a-b formed on its peripheral surface,the grooves 424 a-b being adapted to engage a pair of tabs 435 a-bformed on a pair of forks 434 a-b extending from the proximal side ofthe cover block 430′ to selectably couple the cover block 430′ to thepusher block 420′.

The cover block 430′ can be disposed on the proximal end region 330 a′of the cover member 330′. As described above, the cover block 430′ caninclude a pair of forks 434 a-b extending from the proximal end of thecover block 430′, each of the forks having an inward directed tab 435a-b that are adapted to engage the grooves 424 a-b on the peripheralsurface of the pusher block 420′ to selectably couple the cover block430′ to the pusher block 420′.

The support block 440′ can be disposed on the proximal end region 340 a′of the support member 340′. As described above, the support block 440′can include a pair of forks 444 a-b extending from the distal end of thesupport block 440′, each of the forks having an inward directed tab 445a-b that are adapted to engage the grooves 413 a-b formed on the surfaceof the carrier block 410′ to selectably couple the support block 440′ tothe carrier block 410′.

The carrier block 410′, pusher block 420′, cover block 430′, and supportblock 440′ are shown in FIGS. 11-13 in their fully coupled state, withthe support block 440′ coupled to the carrier block 410′, the pusherblock 420′ coupled to the carrier block 410′, and the cover block 430′coupled to the pusher block 420′. In this arrangement, the carrierassembly 300′ can include a coaxial set of tubes (as shown, for example,in FIG. 3A), with the support member 340′ slidably retainedsubstantially within the carrier member 310′, which is in turn slidablyretained substantially within the pusher member 320′, which is in turnslidably retained substantially within the cover member 330′.

The triggering system 400′ of the alternative embodiment of theapparatus can include an energy storing element that is used in thefinal stage of the closure element 500 delivery process. The energystoring element, which can be a spring such as the pusher spring 425′shown in FIGS. 10A-10B, can be substantially retained in a spring cavity417′ formed in the carrier block 410′ and coaxially surrounds a proximalportion 310 a′ of the carrier member 310′. The pusher spring 425′ can becapable of expanding and contracting, storing potential energy as it iscontracted and releasing energy as it expands. In its fully expandedstate, the pusher spring 425′ can have a length that is greater than thelength of the spring cavity 417′. The cross-sectional dimension of thepusher spring 425′ can be such that it backs up against and contacts theproximal end of the pusher block 420′. Thus, when the pusher spring 425′is in place between the carrier block 410′ and the pusher block 420′,the pusher spring 425′ can be capable of imparting a force biasing thecarrier block 410′ away from the pusher block 420′.

Prior to delivery of the closure element 500, the distal end of thecarrier block 410′ can be in physical contact with the proximal end ofthe pusher block 420′. In this pre-delivery condition, the pusher spring425′ can be in a contracted state and can be maintained fully within thespring cavity 417′ formed in the carrier block 410′. A catch member 418′can serve the function of maintaining the carrier block 410′ and pusherblock 420′ in the pre-delivery condition against the spring force of thepusher spring 425′, the force of which would otherwise force apart thecarrier block 410′ from the pusher block 420′. The catch member 418′ canbe a U-shaped piece of metal, plastic, or other rigid material thatengages a first groove 418 a formed on the surface of the carrier block410′ and a second groove 418 b formed on the surface of the pusher block420′. The pusher block 420′ can include a hole 426′ extending through aportion thereof, with one end of the hole 426′ opening into the groove418 b. The hole 426′ can be adapted to receive a trip pin 427′. Duringthe closure element deployment process, the trip pin 427′ can beadvanced through the hole 426′, where it can encounter the catch member418′ that is retained in the groove 418 b. Further advancement of thetrip pin 427′ can cause the catch member 418′ to become disengaged fromthe groove 418 b, thereby releasing the restraining force on the pusherspring 425′.

The operation of the triggering system 400′ of the alternativeembodiment of the apparatus 100′ is illustrated in FIGS. 11-14 with theclosure element 500 (shown in FIGS. 6A-6B) disposed substantially withinthe apparatus 100′. As shown in FIGS. 11A-11B, the apparatus can have aninitial position in which the locator assembly block 280′ is extendedproximally and the triggering system 400′ is in its most proximalposition. Accordingly, the locator control system 200′ is in itsunexpanded state, as shown. At a point in time that the distal endregion 210 b′ of the locator assembly 200′ has been positioned asdesired (for example, within the blood vessel 600), the locator assemblyblock 280 is depressed distally, as shown in FIG. 12, therebytransitioning the locator assembly to the expanded state and,simultaneously, releasing the triggering system 400′ from the initialposition (in the manner described above) such that the triggering systemcan be advanced distally within the housing 380′.

The triggering system 400′ can be advanced distally within the housing380′, thereby advancing the tube set 305 into position adjacent theblood vessel. At a first predetermined position, shown in FIG. 13, thesupport block 440′ can encounter a support stop (not shown) on theinterior surface of the housing bottom half 380 d that inhibits thesupport block 440′ from advancing further distally. As a result, anapplication of additional distal force to the triggering system 400′ cancause the support block 440′ to decouple from the carrier block 410′, asshown in FIG. 13. More specifically, the tabs 445 a-b on the forks 444a-b of the support block 440′ can disengage from the grooves 413 a-b onthe carrier block 410′. Thus, the support block 440′ can remain in theposition shown in FIG. 13, while the carrier block 410′ is able toadvance further distally upon application of force to the triggeringsystem 400′.

Turning to FIGS. 14A-14B, as the triggering system 400′ can be advancedfurther distally, the cover block 430′ engages a cover stop on theinterior surface near the distal end of the housing 380′, therebyinhibiting additional distal advancement of the cover block 430′. Inaddition, the trigger extension 405′ can engage the handle 391′ on theexterior of the apparatus, thereby inhibiting additional distaladvancement of the carrier block 410′. At this point, the distal end ofthe tube set corresponds generally to the state illustrated in FIG. 8G,prior to deployment of the closure element 500.

The closure element 500 can be deployed by releasing the pusher spring425′, which causes the pusher block 420′ (and, thus, the pusher member320′) to advance distally, deploying the closure element in the mannerdescribed above. The pusher spring 425′ can be released by disengagingthe catch member 418′ from the groove 418 b on the pusher block 420′,thereby releasing the pusher spring 425′ to force the pusher block 420′and, thus, the pusher member 320′ —distally relative to the carrierblock 410′. This action can cause the pusher member 320′ to deploy theclosure element 500, as shown, for example, in FIGS. 8H-8L. The catchmember 418′ can be disengaged from the groove 418 b by applying a forceto the trigger 401′, which, in the deployment position, is aligned withthe trip pin 427′ retained in the pusher block 420′. A trigger spring402′ can bias the trigger outward relative to the housing 380′. The usercan apply an inward directed force to the trigger 401′ to counteract thebiasing force of the trigger spring 402′ and force the trigger 401′against the trip pin 427′.

In addition to deploying the closure element 500, the distal advancementof the pusher block 420′ can also cause the locator release system 490′to activate, thereby transitioning the locator control system 200′ fromthe expanded state to the unexpanded state. As the pusher block 420′advances distally to deploy the closure element 500′ in the mannerdescribed above, the pusher block 420′ can also engage the engagementmember 493′ of the locator release system 490′ and advances the locatorrelease rod 491′ distally. This action can cause the release tab spacerblock 492′ to disengage from the release tabs 284 a-b on the locatorassembly block 280′ (see FIG. 15), thereby releasing the locatorassembly block 280′, which returns to its proximal position, causing thelocator assembly 200′ to return to the unexpanded state.

The closure element 500 deployment and locator release actions can occurnearly simultaneously, as illustrated in FIGS. 8I-8K. As describedpreviously, the apparatus 100 can be brought into contact with the bloodvessel 600 by inserting and advancing the distal end of the apparatusthrough an introducer sheath 640 to the blood vessel location. The useof an introducer sheath 640 is not necessary, as the apparatus can beused to deploy the closure element 500 without the use of an introducersheath 640. Furthermore, as described above, when an introducer sheath640 is used, the locator assembly 200, 200′ and the carrier assembly300, 300′ may have cross-sectional dimensions that allow them to bereceived within the introducer sheath 640 either without causing radialexpansion or splitting of the sheath, or with causing radial expansionor splitting of the sheath. If the relative cross-sectional dimensionsof the introducer sheath 640 and carrier assembly 300, 300′ are suchthat the introducer sheath 640 is intended to be split duringadvancement of the carrier assembly 300, 200′, a sheath cutter 701′having a pointed tip 702′ may be utilized to initiate a split at theproximal end of the introducer sheath 640. The sheath cutter 701′ can beadvantageously placed coaxially over the cover member 330′ and can beattached to the distal end of the housing 380′ (FIGS. 11A-11B), wherebyit will initiate a split in the introducer sheath 640. Distaladvancement of the carrier assembly 300, 300′ causes the initial splitat the proximal end of the sheath to advance as the carrier assembly300, 300′ advances, as will be understood by those skilled in the art.

Another alternative embodiment of a clip applier for sealing openingsthrough tissue is shown in FIGS. 16-19. The embodiment of FIGS. 16-19,as described below, has many identical or similar structures thatperform identical or similar functions to the embodiments describedabove and in reference to the preceding Figures. Accordingly, thedescription below should be considered in view of the descriptions aboveof the preceding embodiments. Furthermore, those of ordinary skill inthe art will appreciate that one or more of the components and/orfeatures of the embodiment shown in FIGS. 16-19 may also be incorporatedin the previously described embodiments, as those components and/orfeatures of the previously described embodiments may optionally beincorporated in the embodiment described below and in reference to FIGS.16-19.

Turning to FIGS. 16 and 16A, the device 1001 can be adapted for use inconjunction with a guidewire in an over the wire deployment methoddescribed below. The device 1001 can have a generally elongated bodythat includes, beginning at its proximal end, an actuator cap 1280, agenerally cylindrical actuator housing 1800, a generally cylindricalrelease barrel 1810, a generally cylindrical main housing 1380, and adistal extension 1010. Several components of a locator assembly, acarrier assembly, and a triggering system can be contained within themain housing 1380, as described more fully below in relation to FIGS. 18and 19. The distal extension 1010 of the device can include an externalprotective sheath 1012 that covers the distal portions of the locatorassembly and carrier assembly. The distal end region 1210 b of thelocator assembly can extend out of the distal end of the protectivesheath 1012.

With particular reference to FIG. 16A, the distal end region 1210 b ofthe locator assembly can include expansion elements 1230 that includesubstantially flexible members 1230′. The substantially flexible members1230′ can be selectively controllable between an unexpanded state (asshown in FIG. 16A) and an expanded state, generally in the mannerdescribed above in relation to FIGS. 2A-2D. As shown in FIG. 16A, thelocator assembly of the alternative embodiment of the device 1001 can beprovided with a central lumen 1003, which can be of a diametersufficient to accommodate a standard guidewire or other structure, asappropriate. As described below, the central lumen 1003 can extendthrough the length of the locator assembly and, thus, through the lengthof the device 1001.

Turning again to FIG. 16, the main housing 1380 can include a pair ofgrips 1392 a-b integrally formed on opposite sides of the main housing1380. The distal end of the main housing 1380 can be gradually tapered1382, with the protective sheath 1012 extending out of its distal end. Acylindrical counter spring 1386 can be located coaxially on the externalsurface of the main housing 1380 and rests, at its distal end, against ashoulder 1384 formed in the main housing just proximal to the section ofthe main housing upon which the grips 1392 are formed. The proximal endof the counter spring 1386 can rest against the release barrel 1810,biasing the release barrel 1810 proximally in relation to the shoulder1384 formed on the main housing 1380. The release barrel 1810 isgenerally cylindrical and coaxially surrounds the main housing 1380. Amechanical linkage 1812 can connect the release barrel 1810 to a releaselever 1814 that cooperates with an actuator block 1282, as describedmore fully below in reference to FIGS. 18 and 19. A longitudinal slot1388 can be formed on each of the main housing 1380 and the releasebarrel 1810, through which extends a lever 1405 that, as describedbelow, is used to advance the carrier assembly in the distal directionto operate the device 1001.

A calibration set screw 1818 can be located on the release barrel 1810near the distal end of the slot 1388. As the user advances the lever1405 distally to deploy the closure element 500 similar to thatdescribed above and shown in FIGS. 6A-6G, the lever 1405 will eventuallyengage the calibration set screw 1818. As described below, furtherdistal advancement of the lever 1405 can cause the actuator block 1282to release, thereby causing the locator assembly to release theexpansion elements 1230 and 1230′ from the expanded state to theunexpanded state. Thus, the setting of the calibration set screw 1818can allow the user to fine tune the synchronization of the release ofthe locator assembly with the deployment of the closure element 500, asdescribed below.

The actuator housing 1800 can be attached by a screw 1802 to theproximal end of the main housing 1380, and extends proximally from themain housing 1380. A longitudinal slot 1804 can be formed in theactuator housing 1800 to accommodate the release lever 1814 and thelinkage 1812 (FIGS. 18-19). The actuator cap 1280 can extend out fromthe proximal end of the actuator housing 1800. The actuator cap 1280 canbe a generally cylindrical body that is coaxial with and generallyinternal of the actuator housing 1800. The actuator cap 1280 can includea slide seal 1288 at its proximal end that is slidable and that providesa fluid-tight seal, as described in more detail below. Additionaldetails concerning the actuator are described below in reference toFIGS. 18 and 19.

Turning to FIGS. 17 and 17A, the proximal end of the device is shown inmore detail. As shown, the slide seal 1288 on the actuator cap 1280 hasbeen slid to an open position to expose the interior of the actuator.The slide seal 1288 can be provided with a pair of tabs 1287 thatcooperates with a pair of slots 1289 formed on the proximal end of theactuator cap 1280 to allow the slide seal 1288 to slide in relation tothe actuator cap 1280. The actuator cap 1280 can include a seal 1281,such as an o-ring, that provides a fluid tight seal with the slide seal1288.

As described above and as shown in FIGS. 17 and 17A, the central lumen1003 can extend longitudinally through the center of the device and isaccessible at the proximal end of the actuator cap 1280 when the slideseal 1288 is in the open position. Additional details concerning thecentral lumen 1003 are described below in relation to the additionalFigures.

FIG. 17 provides additional detail concerning the shape and orientationof the grips 1392 a-b formed on the main housing. As shown, the grips1392 a-b can extend radially outward on opposite sides of a point nearthe distal end of the main housing 1380, and provide the user with theability to grip the housing with two fingers while operating the lever1405 with the user's thumb. Also shown in FIGS. 17 and 17A is the slot1804 formed in the actuator housing 1800 to accommodate the releaselever 1814.

FIGS. 18, 18A, and 18B show a cross-section of the proximal portion ofthe device 1001, including the previously described main housing 1380,the release barrel 1810 located coaxially in a slidable relation on theexternal surface of the main housing, the counter spring 1386 thatbiases the release barrel proximally relative to the shoulder 1384formed on the main housing, the actuator housing 1800 extendingproximally from the proximal end of the main housing, the linkage 1812and release lever 1814 connected to the release barrel 1810, and theactuator cap 1280 extending proximally from the proximal end of theactuator housing 1800. The actuator cap 1280 can be attached to, orformed integrally with, an actuator block 1282 that is generallycylindrical and that is adapted to slide longitudinally within anactuator base 1284. The actuator base 1284, in turn, can be attached bythe screw 1802 to the proximal end of the main housing 1380 and thedistal end of the actuator housing 1800, as shown in FIG. 18.

The central lumen 1003 is shown extending through the length of thedevice along its longitudinal axis. The central lumen 1003 can bedefined by the interior diameter of the tubular body 1210 of the locatorassembly 1200, which extends from the proximal end region 1210 a to adistal end region 1210 b (FIG. 16A). The proximal end region 1210 a ofthe tubular body 1210 can be attached or otherwise connected to theactuator block 1282 such that when the actuator block 1282 is advanceddistally the tubular body 1210 is also advanced distally, therebycausing the flexible members 1230′ to buckle and/or expand transverselyoutwardly, (in the manner described above, for example, in relation toFIGS. 2A-2D), thereby transitioning the distal end region 1210 b of thelocator assembly 1200 from the unexpanded state to the expanded state.For example, in FIG. 18, the actuator cap 1280 is shown in the extendedposition, consistent with the locator assembly 1200 being in theunexpanded state. In FIG. 19, the actuator cap 1280 is shown in thedepressed position, consistent with the locator assembly 1200 being inthe expanded state. An actuator spring 1286 can be located in a chamber1285 formed within the interior of the device between the distal end ofthe actuator block 1282 and the actuator base 1284 attached to theproximal end of the main housing 1380 and the distal end of the actuatorhousing 1800. The actuator spring 1286 can bias the actuator block 1282in the proximal direction. Depressing the actuator cap 1280 can causethe actuator spring 1286 to compress within the chamber 1285. Once theactuator cap is fully depressed, the release lever 1814 can be rotatedinwardly such that a catch 1816 formed on the release lever engages aslot 1283 formed on the actuator block 1282, thereby holding theactuator block 1282 in place in the depressed position against thespring force of the actuator spring 1286. The release lever 1814 may bedisengaged, thus transitioning the locator assembly 1200 from theexpanded state to the unexpanded state, either by manually releasing therelease lever 1814 from the actuator block 1282 and allowing theactuator block to extend proximally, or by advancing the carrierassembly lever 1405 distally to engage the calibration set screw 1818 onthe release barrel 1810 and applying additional distal force to thelever 1405 (and, thus, the release barrel 1810) to cause the releaselever 1814 to disengage from the actuator block 1282.

A tube set 1305 can be located within the interior of the main housing1380, extending distally through the distal extension 1010. The tube set1305 shown in FIG. 18 includes a carrier tube 1310, a pusher tube 1320,and a cover tube 1330, each located in a coaxial orientation with eachother and with the tubular body 1210 of the locator assembly 1200. Thetube set 1305 can have a structure otherwise substantially identical tothat described above in relation to FIGS. 3A-3E. The cover tube 1330 canbe connected or otherwise attached at its proximal end to a cover block1430. The pusher tube 1320, similarly, can be connected or otherwiseattached at its proximal end to a pusher block 1420. Finally, thecarrier tube 1310 can be connected or otherwise attached at its proximalend to a carrier block 1410. The lever 1405 can be attached to thepusher block 1420. Thus, any movement of the lever 1405 may cause thepusher block 1420 to move as well.

A leaf spring 1418 can connect the carrier block 1410 to the pusherblock 1420, as shown in FIG. 18B. The leaf spring 1418 can be generallyflat and can extend longitudinally parallel to the central axis of thedevice. A lip 1419 can be formed on the distal end of the leaf spring1418, the lip 1419 oriented such that it engages the distal end of thepusher block 1420, effectively locking the pusher block 1420 to thecarrier block 1410 until the leaf spring 1418 is disengaged from thepusher block 1420, as described below. As long as the pusher block 1420is thereby locked to the carrier block 1410, advancement of the lever1405 may cause advancement of the combination of the carrier block 1410and the pusher block 1420.

A guide pin 1900 can be located and fixed on the interior of the mainhousing 1380, and can extend proximally from the distal wall of theinterior of the main housing. The guide pin 1900 can be received withina slot 1902 formed in the pusher block 1420 and cover block 1430, andcan prevent the pusher block 1420 and cover block 1430 from rotatinginside the main housing 1380.

A grooved pin 1910 can be located and fixed on the interior of the mainhousing 1380, and can extend proximally from the distal wall of theinterior of the main housing 1380. The grooved pin 1910 can be locatedon an opposite side of the interior of the main housing from the guidepin 1900. The grooved pin 1910 can have a taper 1912 formed on itsproximal end and a transverse groove 1914 formed just distally from thebeginning of the taper 1912. The location and orientation of the groovedpin 1910 can be such that the taper 1912 formed on the grooved pin 1910engages and lifts the leaf spring 1418 from its engagement with thepusher block 1420 as the pusher block 1420 and carrier block 1410 areadvanced distally within the device. As the pusher block 1420 andcarrier block 1410 are advanced still further, the lip 1419 formed onthe leaf spring 1418 can engage and lock in place in the transversegroove 1914 formed on the grooved pin 1910, thereby preventing thecarrier block 1410 (and, thus, the carrier tube 1310) from advancing anyfurther distally. This position of the device also corresponds to theengagement of the lever 1405 with the calibration set screw 1818 (FIG.16). Any additional distal movement of the lever 1405 may cause thepusher block 1420 to move further distally while the carrier block 1410remains stationary, thus causing the pusher tube 1320 to deploy theclosure element 1500, in the manner described above in relation to FIGS.8A-8L. This additional distal movement of the lever 1405 maysimultaneously cause the release barrel 1810 to move distally and todisengage the release lever 1814 from the actuator block 1282, therebyreleasing the actuator block 1282 and causing the locator assembly 1200to transition from the expanded state to the unexpanded state.

Referring now to FIGS. 20A-20G, methods of use of the device 1001 inaccordance with the present invention will be described. As previouslydescribed above and shown in FIGS. 16-19, the device 1001 can beconfigured to deploy a closure element 500 over a wire, wherein the overthe wire deployment method utilizing the device 1001 described hereinmay for example include the following steps, though methods of useassociated with the apparatus should not be limited to those describedherein or shown in the appended drawings.

Referring now to FIG. 20A, there is shown a vessel wall 620 disposedbelow a patient's tissue 630 and skin 650, wherein a guidewire 1950 isshown disposed through an opening formed in the vessel and tissue asdescribed above. The guidewire 1950 may be introduced into the bloodvessel for the sole purpose of using the device 1001 to deploy theclosure element 500″, or the guidewire may have already been presentfrom a previously completed interventional procedure. If an introducersheath is in place, it should be removed prior to use of the apparatus1001, thereby leaving the guidewire 1950 in place extending into theblood vessel.

As shown in FIG. 20B, the device 1001 can be threaded over the guidewire1950 by inserting the proximal end of the guidewire 1950 into thecentral lumen of the device 1001 at the distal end of the device, theguidewire is disposed through the device and exits at the proximal endof the device. The device 1001 can be advanced along the guidewire untilthe distal end 210 b of the locator assembly is disposed through theopening formed in the blood vessel as shown in FIG. 20C, whereby thecorrect position of the device is confirmed by observing a slight flowof blood out of the proximal end of the device, through the open slideseal 1288 on the actuator cap 1280 (FIG. 18).

Once the correct position of the device is confirmed, the actuator cap1280 can be depressed (i.e., the actuator block 1282 is advanceddistally) to deploy the flexible members on the distal end 210 b of thelocator assembly, i.e., to transition the locator assembly from theunexpanded state to the expanded state. In the expanded state, theflexible members can engage the inside of the vessel wall at thelocation of the opening in the blood vessel as shown in FIG. 20D. Thecorrect position of the device at this point may be confirmed by gentlypulling on the device to feel the resistance of the vessel wall againstthe flexible members in the expanded state as shown in FIG. 20E. Afterverifying the correct position in this manner, the guidewire may beremoved from the vessel and from the device by withdrawing the guidewirethrough the proximal end of the device. Once the guidewire is removed,the slide seal 1288 on the actuator cap 1280 may be closed to preventfurther flow of blood through the device.

Referring now to FIGS. 20F and 20G, the device 1001 is in the properposition to deploy the closure element 500″. The closure element 500″can be deployed by advancing the lever 1405, which advances the carrierblock 1410, pusher block 1420, and cover block 1430 until further distaladvancement of the carrier block 1410 and cover block 1430 are preventedby the interaction of the leaf spring 1418 engaging and locking in placein the transverse groove 1914 formed on the grooved pin 1910, therebypreventing the carrier block 1410 (and, thus, the carrier tube 1310)from advancing any further distally. Further distal advancement of thelever 1405 thereafter can cause advancement only of the pusher block1420, which causes deployment of the closure element 500 in theidentical manner described above, for example, in relation to FIGS.8H-L. In addition, further distal advancement of the lever 1405 cancause the lever 1405 simultaneously to engage the release barrel 1810,which in turn pulls the release lever 1814 and frees the actuator block1282 to spring back proximally, transitioning the locator assembly 1200from the expanded state to the unexpanded state. The closure elementdeployment and locator release actions can occur nearly simultaneously,as illustrated, for example, in FIGS. 8I-8K.

As shown in FIG. 20G, the closure element 500 is shown in a deployedposition, wherein the closure element has been engaged with the vesselwall to effectively close the opening formed therein. As previouslydescribed and shown in FIGS. 20F and 20G, the closure element 500 can beexpanded as it is deployed from the device 1001, wherein by increasingthe diameter of the closure element 500, the closure element may engagetissue adjacent the opening in the tissue. It is contemplated that theclosure element may be configured to penetrate the vessel wall to effecta closure, or partially penetrate the vessel wall to effect closure.

Another alternative embodiment of a clip applier for sealing openingsthrough tissue is shown in FIGS. 21A-21E. The embodiment of FIGS.21A-21E, as described below, has many identical or similar structuresthat perform identical or similar functions to the embodiments describedabove and in reference to the preceding figures. Accordingly, thedescription below should be considered in view of the descriptions aboveof the preceding embodiments. Furthermore, those of ordinary skill inthe art will appreciate that one or more of the components and/orfeatures of the embodiment shown in FIGS. 21A-21E may also beincorporated in the previously described embodiments, as thosecomponents and/or features of the previously described embodiments mayoptionally be incorporated in the embodiment described below and inreference to FIGS. 21A-21E.

Turning to FIGS. 21A-21E, the carrier assembly 2000 can include a tubeset 2305 having a carrier tube 2310, a pusher tube 2320, a support tube2340, and a cover tube 2330. The carrier tube 2310, the pusher tube2320, the support tube 2340, and the cover tube 2330 can be provided asa plurality of nested, telescoping tubes with a common longitudinal axis2350 as illustrated in FIG. 21A. While the carrier assembly 2000 isdescribed as having a tube set 2305, such tubes can be exchanged withother members with substantially similar functionalities as describedherein.

As shown, the carrier tube 2310 can be configured to receive and supportthe closure element 2500. While being disposed on the carrier tube 2310,the closure element 2500 can be deformed from the natural, planarorientation to form the substantially tubular orientation (shown inFIGS. 6F-6G). Being disposed substantially about and supported by anouter periphery 2312 of the carrier tube 2310, the substantially tubularclosure element 2500 can be substantially in axial alignment with thecarrier tube 2310 with the tines 2520 pointed substantially distally andparallel with the tube set 2305.

Additionally, the carrier assembly 2000 can be operable with a splitter2012. The splitter 2012 can be configured to include at least onesplitting face 2014 that can split various members of the tube set 2305.Also, the splitter 2012 can be configured to radially dilate oroutwardly expand the tines 2520 or body of the substantially tubularclosure element 2500 by having a splitter body that increases incross-section from the proximal end 2012 a to the distal end 2012 b.Also, the splitter 2012 can be moved axially with respect to the tubesof the tube set 2305 by being coupled via a coupling to a wire 2010,such as a guide wire, in order to facilitate placement of the closureelement 2500. However, the wire 2010 can be substituted with a tube,rod, elongate member, or the like. Moreover, the splitter 2012 cancooperate with tubes of the tube set 2305 that are configured to splitso that the tubes can expand around the splitter 2012 and increase inouter diameter as they move distally with respect to the splitter 2012,which can be useful for directing the tines 2520 in an outward-radialdirection.

As shown in FIG. 21B, the carrier tube 2310 can have a proximal endregion 2310 a and a distal end region 2310 b. Also, the carrier tube2310 can include a predetermined length 2318 a, a predetermined outerdiameter 2318 b, and a predetermined inner diameter 2318 c, any of whichcan be of any suitable dimension. The carrier tube 2310 can be formed asa substantially rigid, semi-rigid, or flexible tubular member; however,other suitable configurations can also be employed. The carrier tube2310 can define a lumen 2314 that extends substantially between theproximal end region 2310 a and the distal end region 2310 b, and can beconfigured to slide relative to the other tubes in the tube set 2305disposed in the lumen 2314.

As illustrated, the carrier tube 2310 can include a body 2311 that isconfigured to radially expand either by stretching or by including slits2022 in the body 2311 that provide the carrier tube 2310 with regionsalong which the carrier tube 2310 can split or separate into multipleportions. As shown, the slits 2022 are generally longitudinally orientedalong the lumen; however, other orientations can be used, such asspirals, zigzags (shown in FIG. 23A), or the like. As such, the carriertube 2310 can have a splitting end 2016 at the distal end region 2310 bconfigured to split and separate by movement of the splitter 2012 and/orthe carrier tube 2310. The splitting end 2016 can include a plurality ofslit openings 2018 a-b that provide a splitting region or portion alongwhich the carrier tube 2310 can separate when receiving a force, such aswhen the splitter 2012 moves from the distal end 2310 b toward theproximal end 2310 a of the carrier tube 2310. The slit openings 2018 canbe spaced apart by portions of the splitting end 2016 that becomecarrier flap ends 2020 after the distal end region 2310 b becomes split.Additionally, the body 2311 can include slits 2022 that extend partiallyor completely along the length 2318 a of the carrier tube 2310. Theslits 2022 can be continuous, intermittent, or composed of perforations.The slits 2022 can (i) extend radially from the lumen to the outerperiphery 2312 of the carrier tube 2310, (ii) partially extend radiallyfrom the lumen toward the outer periphery 2312 of the carrier tube 2310,or (iii) partially extend radially from the outer periphery 2312 of thecarrier tube 2310 toward the lumen. For example, when the splitter 2012interacts with the carrier tube 2310, the slits 2022 a and 2022 b cansplit and separate so as to form carrier flaps 2024. The carrier flaps2024 can bend or deform outwardly, and carry the closure element 2500during deployment.

In an alternative to other embodiments, the outer diameter 2318 b of thecarrier tube 2310 can be substantially uniform such that the distal endregion 2310 b of the carrier tube 2310 has a cross-section similar tothe proximal end region 2310 a. However, it may be beneficial for thedistal end region 2310 b to be expandable or configured in such a waythat the outer diameter 2318 b can selectively expand or bend outwardlyso that the closure element 2500 and/or tines 2520 can be expandedduring deployment. This can include expanding at least the distal end ofthe substantially tubular closure element 2500 beyond the naturalcross-section when being deployed; however, the entire closure element2500 can be expanded with the distal end being expanded before theproximal end. The carrier flaps 2024 separate and radially expand orbend outwardly so as to expand the closure element 2500.

As shown in FIG. 21C, the pusher tube 2320 can be configured to distallypush and/or deploy the substantially tubular closure element 2500. Assuch, the pusher tube 2320 can have a proximal end region 2320 a and adistal end region 2320 b and can be coupled with, and slidable relativeto, the carrier tube 2310. The pusher tube 2320 can include apredetermined length 2328 a, a predetermined outer diameter 2328 b, anda predetermined inner diameter 2328 c, any of which can be of anysuitable dimension. The pusher tube 2320 can be configured to slidablyreceive the carrier member 2310 in the lumen 2324 of the pusher tube2320 such that the distal end region 2320 b of the pusher tube 2320 canbe offset proximally from the distal end region 2310 b of the carriertube 2310. As desired, the predetermined length 2328 a of the pushertube 2320 can be greater than or substantially equal to thepredetermined length 2318 a of the carrier tube 2310. The predeterminedlength 2328 a of the pusher tube 2320, however, can be less than thepredetermined length 2318 a of the carrier tube 2310 such that thecarrier tube 2310 and the pusher tube 2320 at least partially define aspace 2360 distal to the distal end region 2320 b of the pusher tube2320 and along the periphery 2312 of the carrier tube 2310. The space2360 can be configured for housing or containing the closure element2500.

The pusher tube 2320 can be formed from a substantially rigid,semi-rigid, or flexible material. Also, the pusher tube 2320 can besubstantially tubular and can define a lumen 2324 that extendssubstantially between the proximal end region 2320 a and the distal endregion 2320 b. The pusher tube 2320 can be configured to slidablyreceive at least a portion of the carrier tube 2310 so that the innerdiameter 2328 c of the pusher tube 2320 is equal to or larger than theouter diameter 2318 b of the carrier tube 2310. The outer diameter 2328b and/or inner chamber 2328 c of the pusher tube 2320 can besubstantially uniform. Also, the distal end region 2320 b of the pushertube 2320 can have one or more longitudinal extensions 2325, whichextend distally from the pusher tube 2320 and along the periphery 2312of the carrier tube 2310. Optionally, the longitudinal extensions 2325can be biased such that the longitudinal extensions 2325 extendgenerally in parallel with a common longitudinal axis 2350, which can beat the guidewire 2010. The longitudinal extensions 2325 can besufficiently flexible to expand radially or bend outwardly, and yetsufficiently rigid to inhibit buckling, as the distal end region 2320 bis directed distally along the carrier tube 2310 and engages thesubstantially tubular closure element 2500 for deployment.

Additionally, the pusher tube 2320 can include a body 2321 that isconfigured to radially expand either by stretching or by including slits2032 in the body 2321 that can separate along the lumen 2324. As shown,the slits 2032 are generally longitudinally oriented; however, otherorientations can be used, such as spirals, zigzags (shown in FIG. 23B),or the like. As such, the pusher tube 2320 can have a splitting end 2026at the distal end region 2320 b configured to split and separate, whichcan be induced by the splitter 2012. The splitting end 2026 can includea plurality of slit openings 2028 a-b that can separate when receiving aforce, such as when the splitter 2012 moves from the distal end 2320 btoward the proximal end 2320 a of the pusher tube 2320. The slitopenings 2028 a-b can be spaced apart by portions of the splitting end2026 that become pushing flap ends 2030 after being split. Additionally,the body 2321 can include slits 2032 that extend partially or completelyalong the length 2328 a of the pusher tube 2320, and can be continuousor intermittent, or composed of perforations. The slits 2032 can (i)extend radially from the lumen 2324 to the outer periphery 2322, (ii)partially extend radially from the lumen 2324 toward the outer periphery2322, or (iii) partially extend radially from the outer periphery 2322toward the lumen 2324. For example, when the splitter 2012 interactswith the pusher tube 2320, the slits 2032 a and 2032 b can split andseparate so as to form pusher flaps 2034. The pusher flaps 2034 can thenretain the pushing capability so as to push the closure element 2500during deployment.

As shown in FIGS. 21A and 21D, a cover tube 2330 can be configured toretain the substantially tubular closure element 2500 substantiallywithin the carrier assembly 2000 prior to deployment. Being coupledwith, and slidable relative to, the pusher tube 2320, the cover tube2330 can have a proximal end region 2330 a and a distal end region 2330b. Also, the cover tube 2330 can include a predetermined length 2338 a,a predetermined outer diameter 2338 b, and a predetermined innerdiameter 2338 c, any of which can be of any suitable dimension.

The cover tube 2330 can be formed as a substantially rigid, semi-rigid,or flexible tubular member. Also, the cover tube 2330 can have an outerperiphery 2332 and have a body 2331 that defines a lumen 2334. The lumen2334 can extend substantially between the proximal and distal endregions 2330 a, 2330 b of the cover tube 2330, and it can be configuredto slidably receive at least a portion of the pusher tube 2320 or anymember of the tube set 2305. When the cover tube 2330 is positionedwithin the carrier assembly 2000, the distal end region 2330 b can beconfigured to extend over the space 2360, thereby defining an annularcavity 2370 for receiving, retaining, and deploying the substantiallytubular closure element 2500.

The outer diameter 2338 b and/or inner diameter 2338 c of the cover tube2330 can be substantially uniform along the length 2338 a, or vary indimensions as desired. Additionally, the distal end region 2330 b of thecover tube 2330 can include one or more longitudinal extensions 2335,which extend distally from the cover tube 2330 and along an outerperiphery 2322 of the pusher tube 2320. Although the longitudinalextensions 2335 can extend generally in parallel with a commonlongitudinal axis 2350, the longitudinal extensions 2335 can also bebiased such that the plurality of longitudinal extensions 2335 extendsubstantially radially inwardly. Thereby, the longitudinal extensions2335 can at least partially close the lumen 2334 substantially adjacentto the distal end region 2330 b of the cover tube 2330. To permit thesubstantially tubular closure element 2500 to be deployed from theannular cavity 2370, the longitudinal extensions 2335 can besufficiently flexible to expand or bend radially outward so as to permitthe distal end region 2310 b of the carrier tube 2310 to move distallypast the cover tube 2330 to open the annular cavity 2370 such that thedistal end region 2330 b no longer extends over the space 2360.

As shown in FIGS. 21A and 21E, the tube set 2305 can include a supporttube 2340. The support tube 2340 can be configured to slidably receivethe wire 2010 that is coupled to the splitter 2012. The support tube2340 can also provide radial support for the other tubes within the tubeset 2305. The carrier assembly 2000 can advantageously include thesupport tube 2340, for example, to provide sufficient support to thecarrier tube 2310 in the instance it is not sufficiently rigid or underother circumstances in which support for the carrier tube 2310 or othertubes in the tube set 2305 might be desirable. Also, the support tube2340 can include slits (not shown) that can provide a region ofseparation similar to those described with respect to the carrier tube2310 and/or pusher tube 2320.

The support tube 2340 can be formed as a substantially rigid,semi-rigid, or flexible tubular member, and have a proximal end region2340 a and a distal end region 2340 b. A body 2342 of the support tube2340 can define a lumen 2344 that extends substantially between theproximal end region 2340 a and the distal end region 2340 b. The lumen2344 can be configured to slidably receive and support at least aportion of the wire 2010 or other type of movable member coupled to thesplitter 2012. The support tube 2340, in turn, can be at least partiallyslidably disposed within the lumen 2314 of the carrier tube 2310 suchthat the wire 2010 may be disposed within, and slidable relative to, thecarrier member 2310.

The support tube 2340 can have a predetermined length 2348 a, apredetermined outer diameter 2348 b, and a predetermined inner diameter2348 c, any of which can be of any suitable dimension. Also, the outerdiameter 2348 b of the support tube 2340 can be substantially uniformand smaller than inner diameter 2318 c of the carrier tube 2310, and theinner diameter 2348 c of the support tube 2340 can be larger than thesize of the wire 2010, a locator tube, or other type of movable memberoperably coupled to the splitter 2012.

In the instance the carrier assembly 2000 is assembled as the pluralityof nested, telescoping members as shown in FIG. 21A, the carrier tube2310 can be at least partially disposed within, and slidable relativeto, the lumen 2324 of the pusher tube 2320. The pusher tube 2320, inturn, can be at least partially disposed within, and slidable relativeto, the lumen 2334 of the cover tube 2330. To operably couple thecarrier assembly 2000 with the splitter 2012, the wire 2010 can be atleast partially disposed within, and slidable relative to, the lumen2314 of the carrier tube 2310. In the instance the carrier assembly 2000includes a support tube 2340 as depicted, the wire 2010 can be disposedwithin, and slidable relative to, the lumen 2344 of the support tube2340. The longitudinal axis of the wire 2010 can be substantially inaxial alignment with the common longitudinal axis 2350 of the carriertube 2310, the pusher tube 2320, the cover tube 2330, and/or the supporttube 2340. Although shown and described as being substantially separatefor purposes of illustration, it will be appreciated that the carriertube 2310, the pusher tube 2320, the cover tube 2330, and/or the supporttub 2340 can be provided, in whole or in part, as one or more integratedassemblies, and the various tubes may be combined.

Another alternative embodiment of a closure element carrier systemhaving a tube splitter for sealing openings through tissue is shown inFIGS. 22A-22E. The embodiment of FIGS. 22A-22E, as described below, hasmany identical or similar structures that perform identical or similarfunctions to the embodiments described above and in reference to thepreceding figures. Accordingly, the description below should beconsidered in view of the descriptions above of the precedingembodiments. Furthermore, those of ordinary skill in the art willappreciate that one or more of the components and/or features of theembodiment shown in FIGS. 22A-22E may also be incorporated in thepreviously described embodiments, and those components and/or featuresof the previously described embodiments may optionally be incorporatedin the embodiment described below and in reference to FIGS. 22A-22E.

Turning to FIGS. 22A-22E, the carrier assembly 2002 can include a tubeset 2605 having a carrier tube 2610, a pusher tube 2620, a splitter tube2680, and a cover tube 2630. The carrier tube 2610, the pusher tube2620, the splitter tube 2680, and the cover tube 2630 can be provided asa plurality of nested, telescoping tubes with a common longitudinal axis2650 as illustrated in FIG. 22A. While the carrier assembly 2002 isdescribed by including a tube set 2605, such tubes can be exchanged withother members with substantially similar functionalities as describedherein.

As shown, the carrier tube 2610 can be configured to receive and supportthe closure element 2500. While being disposed on the carrier tube 2610,the closure element 2500 can be deformed from the natural, planarorientation to form the substantially tubular orientation (shown inFIGS. 6F-6G). Being disposed substantially about, and supported by, anouter periphery 2612 of the carrier tube 2610, the substantially tubularclosure element 2500 can be substantially in axial alignment with thecarrier tube 2610 with the tines 2520 pointed substantially distally andparallel with the tube set 2605.

Additionally, the carrier assembly 2002 can be operable with a splittertube 2680, which includes a support tube 2640 coupled to a splitter2070. The splitter 2070 can be configured to include at least onesplitting face 2074 that can split various members of the tube set 2605.Also, the splitter 2070 can be configured to radially-dilate oroutwardly expand the tines 2520 or body of the substantially tubularclosure element 2500. In part, this is because the splitter 2070 canhave a body that increases in dimension from the proximal end 2070 a tothe distal end 2070 b. Also, the splitter 2070 can be moved axially bymoving the splitter tube 2680 with respect to the other tubes of thetube set 2605 in order to facilitate placement of the closure element2500. Moreover, the splitter tube 2680 can cooperate with the othertubes of the tube set 2605 that are configured to split so that thetubes can expand around the splitter and increase in outer diameter orbend outwardly as they move distally with respect to the splitter 2070,which can be useful for expanding the closure element 2500 and/ordirecting the tines 2520 in an outward-radial direction.

As shown in FIG. 22B, the carrier tube 2610 can have a proximal endregion 2610 a and a distal end region 2610 b. Also, the carrier tube2610 can include a predetermined length 2618 a, a predetermined outerdiameter 2618 b, and a predetermined inner diameter 2618 c, any of whichcan be of any suitable dimension. The carrier tube 2610 can be formed asa substantially rigid, semi-rigid, or flexible tubular member; however,other suitable configurations can also be employed. The carrier tube2610 can include a body 2611 that defines a lumen 2614 that extendssubstantially between the proximal end region 2610 a and the distal endregion 2610 b.

The carrier tube 2610 can include a portion 2613 of the body 2611 thatis configured to radially expand either by stretching or by includingslits 2052 in the portion 2613 that can separate along the lumen 2614.As shown, the slits 2052 are generally longitudinally oriented; however,other orientations can be used, such as spirals, zigzags (shown in FIG.24A), or the like. As such, the carrier tube 2610 can have a splittingend 2046 at the distal end region 2610 b configured to split andseparate when interacting with the splitter 2070. The splitting end 2046can include a plurality of slit openings 2048 a-b that provide a regionalong which the carrier tube 2610 can separate when receiving a force,such as when the splitter 2070 moves from the distal end 2610 b towardthe proximal end 2610 a of the carrier tube 2610. The slit openings 2048can be spaced apart by portions of the splitting end 2046 that becomecarrier flap ends 2050 after being split. Additionally, the portion 2613can include slits 2052 that extend partially down the length 2618 a ofthe carrier tube 2610. The slits 2052 can be continuous, intermittent,or composed of perforations. The slits 2052 can (i) extend radially fromthe lumen 2614 to the outer periphery 2612, (ii) partially extendradially from the lumen 2614 toward the outer periphery 2612, or (iii)partially extend radially from the outer periphery 2612 toward the lumen2614.

As shown, each of the slits 2052 can terminate at a slit end 2056. Aslit end 2056 can be a member that inhibits the propagation of cracks orsplitting, which can be exemplified by an aperture, hole, recess,reinforcement, dead end, or the like. For example, when the splitter2070 interacts with the carrier tube 2610, the carrier tube 2610 splitsalong the slits 2052 a and 2052 b to form the carrier flap 2054. Thecarrier flap 2054 can expand radially or bend outwardly to carry theclosure element 2500 during deployment.

In an alternative to other embodiments, the outer diameter 2618 b of thecarrier tube 2610 can be substantially uniform such that the distal endregion 2610 b of the carrier tube 2610 can have a cross-section similarto the proximal end region 2610 a. However, it may be beneficial for thedistal end region 2610 b to be expandable or configured in such a waythat the outer diameter 2618 b can selectively expand so that theclosure element 2500 and/or tines 2520 can be expanded duringdeployment. This can include expanding at least the distal end of thesubstantially tubular closure element 2500 beyond the naturalcross-section when being deployed; however, the entire closure element2500 can be expanded. The carrier flaps 2054 separate and radiallyexpand or bend outwardly so as to expand the closure element 2500 duringdeployment.

As shown in FIG. 22C, the pusher tube 2620 can be configured to distallypush and/or deploy the substantially tubular closure element 2500 overthe carrier tube 2610. As such, the pusher tube 2620 can have a proximalend region 2620 a and a distal end region 2620 b and can be coupledwith, and slidable relative to, the carrier tube 2610. The pusher tube2620 can include a predetermined length 2628 a, a predetermined outerdiameter 2628 b, and a predetermined inner diameter 2628 c, any of whichcan be of any suitable dimension. The pusher tube 2620 can be configuredto slidably receive the carrier member 2610 in a lumen 2624 such thatthe distal end region 2620 b of the pusher tube 2620 can be offsetproximally from the distal end region 2610 b of the carrier tube 2610.As desired, the predetermined length 2628 a of the pusher tube 2620 canbe greater than or substantially equal to the predetermined length 2618a of the carrier tube 2610. The predetermined length 2628 a of thepusher tube 2620, however, can be less than the predetermined length2618 a of the carrier tube 2610 such that the carrier tube 2610 and thepusher tube 2620 at least partially define a space 2660 distal to thedistal end region 2620 b of the pusher tube 2620 and along the periphery2612 of the carrier tube 2610. The space 2660 can be configured forhousing or containing the closure element 2500.

The pusher tube 2620 can be formed from a substantially rigid,semi-rigid, or flexible material. Also, the pusher tube 2620 can besubstantially tubular and can define the lumen 2624 that extendssubstantially between the proximal end region 2620 a and the distal endregion 2620 b. The lumen 2624 can be configured to slidably receive atleast a portion of the carrier tube 2610 so that the inner diameter 2628c of the pusher tube 2620 is equal to or larger than the outer diameter2618 b of the carrier tube 2610. The inner diameter 2628 c and the outerdiameter 2628 b of the pusher tube 2620 are substantially uniform.

Also, the distal end region 2620 b of the pusher tube 2620 can includeone or more longitudinal extensions 2625, which extend distally from thepusher tube 2620 and along the periphery 2612 of the carrier tube 2610.The longitudinal extensions 2625 can be biased such that thelongitudinal extensions 2625 extend generally in parallel with a commonlongitudinal axis 2650. The longitudinal extensions 2625 can besufficiently flexible to expand radially or bend outwardly and yetsufficiently rigid to inhibit buckling. Thus, the longitudinalextensions 2625 can be configured so as to engage and push thesubstantially tubular closure element 2500 over the carrier tube 2610for deployment.

Additionally, the pusher tube 2620 can include a portion 2623 of a body2621 that is configured to radially expand or bend outwardly either bystretching or by including slits 2062 in the portion 2623 along whichthe pusher tube 2620 can separate along the lumen 2624. As shown, theslits 2062 are generally longitudinally oriented; however, otherorientations can be used, such as spirals, zigzags (shown in FIG. 24B),or the like. As such, the pusher tube 2620 can have a splitting end 2068at the distal end region 2620 b configured to split and separate, whichcan be induced by the splitter 2070. The splitting end 2068 can includea plurality of slit openings 2058 a-b that provide a splitting region orportion along which the pusher tube 2620 can separate when receiving aforce, such as when the splitter 2070 moves from the distal end 2620 bto the proximal end 2620 a. The slit openings 2058 a-b can be spacedapart by portions of the splitting end 2068 that become pushing flapends 2060 after being split. Additionally, the portion 2623 can includeslits 2062 that extend partially down the length 2628 a of the pushertube 2620. The slits 2062 and can be continuous, intermittent, orcomposed of perforations. The slits 2062 can (i) extend radially fromthe lumen to the outer periphery 2622 of, (ii) partially extend radiallyfrom the lumen toward the outer periphery 2622, or (iii) partiallyextend radially from the outer periphery 2622 toward the lumen.

As shown, the slits 2062 can terminate at a slit end 2066. A slit end2066 can be a member that inhibits the propagation of cracks orsplitting, which can be exemplified by an aperture, hole, recess,reinforcement, dead end, or the like. For example, when the splitter2070 interacts with the pusher tube 2620, the slits 2062 a and 2062 bcan split and separate so as to form pusher flaps 2064. The pusher flaps2064 can then retain the pushing capability so as to push the closureelement 2500 over the carrier tube 2610 during deployment.

As shown in FIGS. 22A and 22D, a cover tube 2630 can be configured toretain the substantially tubular closure element 2500 substantiallywithin the carrier assembly 2002 prior to deployment. The cover tube2630 can be coupled with, and slidable relative to, the pusher tube2620. The cover tube 2630 can have a proximal end region 2630 a and adistal end region 2630 b. Also, the cover tube 2630 can include apredetermined length 2638 a, a predetermined outer diameter 2638 b, anda predetermined inner diameter 2638 c, any of which can be of anysuitable dimension. The cover tube 2630 can be configured substantiallysimilarly as described in connection with FIG. 21D.

Additionally, the distal end region 2630 b of the cover tube 2630 caninclude one or more longitudinal extensions 2635, which extend distallyfrom the cover tube 2630 and along an outer periphery 2622 of the pushertube 2620. Although the longitudinal extensions 2635 can extendgenerally in parallel with common longitudinal axis 2650, thelongitudinal extensions 2635 can be biased such that the plurality oflongitudinal extensions 2635 extend substantially radially inwardly.Thereby, the longitudinal extensions 2635 can at least partially closethe lumen 2634 substantially adjacent to the distal end region 2630 b ofthe cover tube 2630. To permit the substantially tubular closure element2500 to be deployed from the annular cavity 2670, the longitudinalextensions 2635 can be sufficiently flexible to expand radially or bendoutwardly so as to permit the distal end region 2610 b of the carriertube 2610 to move distally past the cover tube 2630 to open the annularcavity 2670 such that the distal end region 2630 b no longer extendsover the space 2660. Also, the longitudinal extensions 2635 can besufficiently expandable so that they can expand around the splitter 2070when moved into or out of the cover tube 2630. The splitter 2070 canalso split the cover tube 2630 as described herein.

As shown in FIGS. 22A and 22E, the tube set 2605 can include a splittertube 2680 having a support tube 2640 coupled to a splitter 2070. Also,the splitter tube 2680 can provide radial support for the other tubeswithin the tube set 2605. The carrier assembly 2002 can advantageouslyinclude the splitter tube 2680, for example, to provide sufficientsupport to the carrier tube 2610 in the instance it is not sufficientlyrigid or under other circumstances in which support for the carrier tube2610 or other tubes in the tube set 2605 might be desirable. It alsowill be appreciated that the splitter tube 2680 can move the splitter2070 with respect to the other tubes in the tube set 2605. This caninclude moving the splitter 2070 so that it can split the carrier tube2610, pusher tube 2620, and/or cover tube 2630.

The splitter tube 2680 can be formed as a substantially rigid,semi-rigid, or flexible tubular member. As such, the splitter tube 2680can include a support tube 2640 having a proximal end region 2640 a anda distal end region 2640 b that it is coupled to the splitter 2070. Thebody 2642 of the support tube 2640 can define a lumen 2644 that extendssubstantially between the proximal end region 2640 a and the distal endregion 2640 b. Additionally, the splitter 2070 can also include a lumen2072 that communicates with the lumen 2644 of the support tube 2640,wherein the lumen 2072 of the splitter 2070 can be the same or differentsizes. The lumens 2644 and 2072 can be configured to slidably receiveand support at least a portion of a wire, a locator tube, or other typeof movable member disposed therein. The support tube 2640 portion of thesplitter tube 2680 can be at least partially slidably disposed withinthe lumen 2614 of the carrier tube 2610 such that the wire may bedisposed within, and slidable relative to, the carrier tube 2610 in themanner described in more detail above. However, the splitter 2070 can bedisposed distally from the splitting end 2046 of the carrier tube 2610such that moving the splitter 2070 in a proximal direction relative tothe splitting end 2046 can cause splitting of the carrier tube 2610 atthe slit openings 2048 and along the slits 2052 to form carrier flaps2054. The splitter 2070 can then be moved proximally with respect to andunder the carrier flaps 2054, which can deform and bend outwardly fromthe splitter face 2074.

Additionally, the support tube 2640 and/or splitter tube 2680 can have apredetermined length 2648 a, a predetermined outer diameter 2648 b, anda predetermined inner diameter 2648 c, any of which can be of anysuitable dimension. Also, the outer diameter 2648 b of the support tube2640 can be substantially uniform and smaller than inner diameter 2618 cof the carrier tube 2610. The inner diameter 2648 c of the support tube2640 can be larger than the size of the wire, locator tube, or othertype of member that can be disposed therein.

In the instance the carrier assembly 2002 is assembled as the pluralityof nested, telescoping members as shown in FIG. 22A, the support tube2640 portion of the splitter tube 2680 can be at least partiallydisposed within, and slidable relative to, the lumen 2614 of the carriertube 2610. However, unless during or after splitting the carrier tube2610, the splitter 2070 is usually disposed distally adjacent to thecarrier tube 2610. Additionally, the carrier tube 2610 can be at leastpartially disposed within, and slidable relative to, the lumen 2624 ofthe pusher tube 2620. The pusher tube 2620, in turn, can be at leastpartially disposed within, and slidable relative to, the lumen 2634 ofthe cover tube 2630. Also, the splitter 2070 can be disposed within thelumen 2634 of the cover tube 2630. In the instance a guidewire and/orlocator tube to be disposed and/or slidable within the lumen 2644 of thesplitter tube 2680 the longitudinal axis thereof can be substantially inaxial alignment with the common longitudinal axis 2650 of the carriertube 2610, the pusher tube 2620, the cover tube 2630, and/or the supporttube 2640. Although shown and described as being substantially separatefor purposes of illustration, it will be appreciated that the carriertube 2610, the pusher tube 2620, the cover tube 2630, and/or thesplitter tub 2680 can be provided, in whole or in part, as one or moreintegrated assemblies.

Additionally, various embodiments of tube splitters that can be usedwith a clip applier for sealing openings through tissue are shown inFIGS. 25A-30B. The embodiments of splitters of FIGS. 25A-30B can havevarious configurations to cooperate and split various tubes of the clipappliers described herein. As such, the splitters can have manyidentical or similar structures that perform identical or similarfunctions to the embodiments described above and in reference to thepreceding figures. Accordingly, the description below should beconsidered in view of the descriptions above of the precedingembodiments of clip appliers and/or splitters. Furthermore, those ofordinary skill in the art will appreciate that one or more of thecomponents and/or features of the embodiments shown in FIGS. 25A-30B mayalso be incorporated in the previously described embodiments, such asFIGS. 21A-22E, and those components and/or features of the previouslydescribed embodiments may optionally be incorporated in the varioussplitter embodiments described below and in reference to FIGS. 25A-30B.Moreover, FIGS. 25A-28 can be characterized as sliding splitters becausethey slid into the lumen of a carrier tube in order to effect splitting.On the other hand, FIGS. 29A-30B can be characterized as expandablesplitters because they expand within the lumen of the carrier tube inorder to effect splitting.

FIGS. 25A-25D are schematic illustrations of different shapes of slidingsplitters. While various shapes are shown, such shapes can be modified,altered, or manipulated between planar and volumetric configurations aslong as the described functionality is retained (e.g., split one or moretubes of a tube set and/or expand the tines of a closure element). FIG.25A is a representation of a polygonal splitter 2402 having arepresentative trapezoidal cross-sectional profile. The polygonalsplitter 2402 can include a feature common with other embodiments, e.g.,having a tapered cross-sectional profile. As such, the splitter 2402 canincrease in cross-sectional profile from the proximal end 2402 a to thedistal end 2402 b. The tapered cross-sectional profile allows theproximal end 2402 a of the splitter 2402 to enter into the lumen of acarrier tube or other tube of a tube set. As the splitter 2402 movesproximally with respect to the tube of the tube set, the cross-sectionalprofile of the splitter 2402 positioned in the lumen of the tube beginsto increase until it is larger than the lumen. At this point, the tubecan split into separate flaps, as described above. Another commonfeature is the splitter being coupled to a movable member, such as awire, tube, rod, elongate member, or the like that can move the splitter2402 into or through a lumen of a tube of the tube set. As depicted, thesplitter 2402 can be coupled at the proximal end 2402 a to a wire 2414.

Alternate configurations of the splitter are illustrated in FIGS.25B-25D. FIG. 25B shows a conical-shaped splitter 2404, FIG. 25C shows ahemispherical splitter 2406, and FIG. 25D shows a spherical splitter2408; however, other shapes can be used.

Referring now to FIG. 26, a schematic representation of anotherembodiment of a splitter 2410 is illustrated. The splitter 2410 caninclude a passage 2411 extending therethrough. While the passage 2411 isdepicted to be substantially at the longitudinal axis, it can bedisposed at any location and in any orientation of the splitter 2410that retains functionality. The passage 2411 can be configured and sizedso that a wire 2414 can be passed therethrough. The wire 2414 can beused for moving the splitter 2410 proximally and/or distally withrespect to any of the tubes in the tube set. In order to facilitatemovement of the splitter 2410, a recess 2412 can be disposed thereinthat can retain a retention member 2416 coupled to the wire 2414. Theretention member 2416 can be any member that is attached to the wire2414 having a dimension that is too large to pass through the passage2411. As such, the retention member 2416 can be trapped within therecess. Alternatively, the recess 2412 can be a substantially closedcompartment, container, cavity, or other configuration configured tohouse the retention member 2416. The retention member 2416 can be acrimp, clamp, brace, fastener, or the like that has a diameter largerthan the wire 2414 and/or the passage 2411.

Referring now to FIGS. 27A-27C, schematic diagrams of embodiments ofsplitters configured to take hold of or grab a portion of tissue to thesplitter. With tissue held by the splitter, or the splitter selectivelyreceiving or securing tissue, the tissue around the opening in thevessel to be closed by the closure element can be pulled. The splittercan optionally function as a locator to aid with positioning the device.

Turing to FIG. 27A, depicted is a toothed splitter 2420. The toothedsplitter 2420 can include one or more teeth 2422 extending from a bodyof the splitter 2420. The teeth 2422 can have various orientations andcan be pointed toward the proximal end 2420 a, normal, or toward thedistal end 2420 b of the toothed splitter 2420. Any number of teeth 2422can be used in any arrangement.

FIG. 27B depicts another configuration of the splitter that can takehold of or grab a portion of tissue. The barbed splitter 2430 of FIG.27B can include one or more barbs 2432. The barbs 2432 can be directedtoward the proximal end 2430 a of the splitter 2430. Additionally, anynumber of barbs 2432 can be used in any arrangement; however, havingbarbs at the distal end 2430 b is particularly beneficial. In part,barbs 2432 at the distal end 2430 b can be particularly advantageous forgrabbing and selectively securing tissue from around the opening of thevessel toward the clip applier and the closure element (e.g., clip) thatwill close the opening.

FIG. 27C depicts yet another configuration of a splitter that can takehold of or grab a portion of tissue. This toothed-barbed splitter 2440can have both teeth 2422 and barbs 2432. In one configuration, the teeth2422 can be disposed from the proximal end 2440 a toward the distal end2440 b, and the barbs 2432 can be disposed at the most distal end 2440 bof the splitter 2440. It will be understood, however, that teeth can bedisposed at the ends of the splitter, while the barbs are disposedbetween the teeth. In still other configurations, the teeth and barbscan be disposed at any location of the splitter and in any number andorientation.

While various embodiments of splitters to take hold of or grab a portionof tissue during a procedure have been depicted and described,modifications can be made thereto that retain the desired functionality.

FIG. 28 is a schematic diagram of an embodiment of a series of splitters2450 configured to nest or combine together and expand for use with aclip applier. The series of splitters 2450 can include a first splitter2452, a second splitter 2458, and a third splitter 2466; however, anynumber of splitters can be used. As depicted, the first splitter 2452can include a first slit 2454 having a first slit opening 2456 that isconfigured to receive a proximal end 2460 of the second splitter 2458,and the second splitter 2458 can include a second slit 2462 having asecond slit opening 2464 configured to receive the proximal end 2468 ofthe third splitter 2466. As the proximal end 2460 of the of the secondsplitter 2458 contacts the first slit opening 2456, the first slit 2454opens to receive the second splitter 2458 therein. As such, the firstslit 2454 can be configured as a hole, recess, aperture, cavity, or thelike. When the second splitter 2458 enters the first slit 2454, thefirst splitter radially expands so as to increase in size. Additionally,the second splitter 2458 and third splitter cooperate so that the secondsplitter 2458 expands. Moreover, as the second splitter 2458 expands,the first splitter 2452 can further expand for a larger size. Thus, thesplitter 2474 can include the following: the first splitter 2452 openedso as to have a cavity 2470 receiving the second splitter 2458; and thesecond splitter 2458 opened so as to have a cavity 2472 receiving thethird splitter 2466.

While only one embodiment of a series of splitters 2450 configured tocombine and expand is illustrated, various other configurations can beused that include more than one splitter combining so as to expand orfurther expand the proximally disposed splitters. The splitters can beconfigured to be moved independently or in combination with each otherby being coupled to a guidewire, tube, rod, elongate element, or thelike that can be slidably disposed within a lumen or aperture of othersplitters in the series.

A clip applier apparatus in accordance with the present invention caninclude an expandable element. An expandable element can be used inplace of any of the slidable tube splitters described herein or inaddition thereto. Also, an expandable element can be selectivelyexpanded in order to split the tubes described herein. An expandableelement can be selectively expanded so that a clip is expanded prior orduring deployment, which can be beneficial for expanding the clip from aretaining orientation that has a narrow orthogonal cross-sectionalprofile. As such, an expandable element can be located at a distal endof the clip applier apparatus, which may be within the lumen of a distalend portion of a carrier tube and/or support tube, and can beselectively expanded when the clip is disposed thereon and/or beingdeployed therefrom.

FIGS. 29A-29B illustrate an embodiment of an expandable member 2100 thatcan be selectively expanded so that the entire expandable member or aportion thereof can be expanded. Accordingly, the expandable member 2100can be configured to be substantially tubular in shape. The expandablemember 2100 can include a plurality of annular elements 2110 a-2110 cthat can have a plurality of crossbars 2120 that are connected togetherby elbows 2130 and intersections 2140. More particularly,circumferentially-adjacent crossbars 2120 can be coupled at an elbow2130 and four or more circumferentially-adjacent crossbars 2120 can becoupled together at an intersection 2140. With this configuration,crossbars 2120, intersections 2140, and elbows 2130 can cooperate so asto form a structure 2170 that allows for flexibility as each structure2170 can expand or collapse in order for the expandable member to beselectively expanded and/or collapsed. In the illustrated configuration,the structure 2170 has a generally diamond shape that can provide theidentified flexibility to the expandable member 2100. Thus, each annularelement 2110 can have a series of circumferentially-interconnectedflexible structures 2170, such as, but not limited to, diamondstructures, that can expand or collapse under the influence of a balloonor change of temperature.

It will be understood that structure 2170 can have other configurationswhile providing flexibility to the endoprosthesis 2100. For instance,structure 2170 could be replaced with a repeating “V”, a repeating “U”,or other structures well known in the art of stents. As such, theexpandable element 2100 can be substantially similar to a stent and canhave the various components and functionalities well known to be used instents, which can allow for selective expansion from a collapsedorientation.

FIG. 29A shows the expandable element 2100 a in a collapsed orientationso that the annular elements 2110 a-2110 c are contracted toward eachother, which can be beneficial for use within a tube set of a clipapplier. In the contracted position, the structure 2170 enables each ofthe annular elements 2110 a-2110 c to flex in the longitudinal, andcross directions. Also, the structure 2170 can allow for each of thefirst annular element 2110 a, second annular element 2110 b, and/orthird annular element 2110 c to be selectively expanded.

FIG. 29B shows the expandable member 2100 b in a selectively expandedorientation so that the annular elements 2110 a-c are outwardlyexpanded. As shown, the first annular element 2110 a is partiallyexpanded with a first end 2102 not expanding or being expanded less thana second end 2104 so as to have a substantially conical shape.Similarly, the second annular element 2110 b and third annular element2110 c are selectively expanded with conical shapes. As such, theexpandable member 2100 b in a selectively expanded orientation can havea substantially conical shape with the proximal end 2102 (i.e., firstend) being less expanded compared to the distal end 2104 (i.e., secondend). In the instance the first end 2102 of the first annular element2110 a does not expand, the crossbars 2120 or elbows 2130 at the firstend 2102 can be coupled together or integrally formed into a continuousannular end.

Additionally, an expandable member can be used as a tube in a tube set.This can include the entire tube being selectively expandable asdescribed herein, or a portion of the tube having the expandable member.For example, a support tube and/or a carrier tube can have a distalportion configured as an expandable member, which can be exemplified byeither of the tubes being coupled to an end of the expandable member.

FIGS. 30A-30B show an embodiment of a selectively expandable carriertube 2600 having a carrier tube 2310 coupled to an expandable member2100. As such, the selectively expandable carrier tube 2180 can have anyof the characteristics and elements described herein with respect to acarrier tube 2310, and can have any of the characteristics and elementsdescribed herein with respect to an expandable member 2100 (see FIGS.29A-29B). FIG. 30A shows the selectively expandable carrier tube 2180 ina collapsed orientation, and FIG. 30B shows the selectively expandablecarrier tube 2180 in a selectively expanded orientation. The selectivelyexpandable carrier tube 2180 can be characterized by a proximal end 2102of the expandable member 2100 being coupled to a distal portion 2610 bof the carrier tube 2610 through a coupling 2106. The coupling 2106 canhold the proximal end 2102 of the expandable member 2100 so that it doesnot expand. This can allow for the expandable element to expand into aconical shape.

Additionally, various methods of using a clip applier having asplittable tube and splitter for delivering closure elements into tissueopenings are shown in FIGS. 31A-32D. The methods can utilize embodimentsof clip appliers and splitters shown in the previous figures. As such,the use of splitters in delivering a clip can be used as shown, and canhave many identical or similar structures that perform identical orsimilar functions to the embodiments described above and in reference tothe preceding figures. For example, the splitter can be configured tomove proximally with respect to the carrier tube carrying the closureelement by being coupled with a wire, a tube, or another element thatcan manipulate the orientation of the splitter with respect to the clipappliers. Accordingly, the description below should be considered inview of the descriptions above of the preceding embodiments of clipappliers and splitters and methods of using the same. Furthermore, thoseof ordinary skill in the art will appreciate that one or more of theuses, components, and/or features of the embodiment shown in FIGS.31A-32D may also be incorporated in the previously describedembodiments, and those components and/or features of the previouslydescribed embodiments may optionally be incorporated in the varioussplitter embodiments described below and in reference to FIGS. 31A-32D.While slidable splitters are depicted and described in connection withFIGS. 31A-32B, expandable splitters may be similarly used wheremodifications in using such expandable splitters are well within thecapabilities of one of ordinary skill in the art.

Turning to FIG. 31A, a sheath 640 may be inserted or otherwisepositioned through skin 650 and tissue 630 and within the blood vessel600 or other body lumen via the opening 610. The sheath 640 can beformed from a substantially flexible or semi-rigid tubular member.Additionally, the sheath 640 has a proximal end region 640 a and adistal end region 640 b and includes a predetermined length and apredetermined cross-section, both of which can be of any suitabledimension. The sheath 640 can form a lumen 644 that extends along alongitudinal axis of the sheath 640 and substantially between theproximal and distal end regions 640 a, 640 b. The lumen 644 can have anysuitable internal cross-section and is suitable for receiving one ormore devices (not shown), such as a catheter, a guide wire, locator, orthe like. The lumen 644 can be configured to slidably receive thetubular body 210 of the locator assembly 200 (shown in FIG. 4A) and/orthe tube set 2605 of the carrier assembly 2002 (shown in FIGS. 22A-22E).

Since the internal cross-section of the sheath 640 typically is lessthan or substantially equal to the predetermined outer diameter of thecover member 2630, the sheath 640 may be configured to radially expand,such as by stretching, to receive the tube set 2605. Alternatively, orin addition, the sheath 640 can be advantageously configured to split,as described in connection to the carrier tube 2610 and/or pusher tube2620. The tube set 2605 can be received by, and advanced within, thelumen 644 of the sheath 640, thereby permitting the apparatus 2002 toaccess the blood vessel wall 620. To facilitate the splitting, thesheath 640 can include one or more splits (not shown), such aslongitudinal splits, each split being provided in the manner known inthe art. Each split can be configured to split the sheath 640 inaccordance with a predetermined pattern, such as in a longitudinal,zigzag, spiral, or like pattern. It will be appreciated that, when theinternal cross-section of the sheath 640 is greater than thepredetermined cross-section of the cover member 2630, it may not benecessary for the sheath 640 to be configured to radially expand and/orsplit. In addition to, or as an alternative to, the apparatus 2002 mayinclude a splitting means, such as a splitter 2070, which initiates atear line or split in the sheath when the sheath is engaged with thedistal end of the apparatus. The sheath 640 can be placed, deployed, andused as described herein or well known in the art.

After the sheath 640 is placed proximate to the blood vessel 600, thelocator assembly 2200 can be received by the lumen 644 of the sheath640. Being in the unexpanded state, the distal end region 2210 b of thetubular body 2210 of the locator assembly 2200 can be slidably receivedby the lumen 644 and atraumatically advanced distally into the bloodvessel 600. Once the distal end region 2210 b of the tubular body 2210can extend into the blood vessel 600, the distal end region 2210 b cantransition from the unexpanded state to the expanded state by activatingthe switching system of the locator assembly 2200.

The locator assembly 2200 and the sheath 640 can be retracted proximallyuntil the distal end region 2210 b is substantially adjacent to an innersurface 620 b of the blood vessel wall 620. The distal end region 2210 bcan thereby draw the blood vessel wall 620 taut and maintains the properposition as the blood vessel 600 pulsates. Since the expandedcross-section of the distal end region 2210 b is greater than orsubstantially equal to the cross-section of the opening 610 and/or thecross-section of the lumen 644, the distal end region 2210 b remains inthe blood vessel 600 and engages the inner surface 620 b of the bloodvessel wall 620. The distal end region 2210 b can frictionally engagethe inner surface 620 b of the blood vessel wall 620, thereby securingthe locator assembly 2200 to the blood vessel 600. The sheath 640 can beretracted proximally such that the distal end region 640 b of the sheath640 is substantially withdrawn from the blood vessel 600 permitting thetube set 2605 to access the blood vessel wall 620.

Once the distal end region 2210 b of the locator assembly 2200 contactsthe inner surface 620 b of the blood vessel wall 620, the splitter tube2680 can be advanced distally toward the outer surface 620 a of theblood vessel wall 620. The splitter tube 2680 can be moved relative tothe other tubes in the tube set 2605 by the support tube 2640 that iscoupled to the splitter 2070. As illustrated by the dashed lines inFIGS. 31A-31B, the splitter 2070 can abut against the outer surface 620a of the vessel 620 such that the locator assembly 2200 and splitter2070 can cooperate to hold the vessel wall 620. After the splitter 2070is at a distal position, the other tubes in the tube set 2605 can thenbe advanced distally and received within the lumen 644 of the sheath.

Alternatively, the splitter tube 2680 can be coupled to the other tubesin the tube set 2605. Being coupled, the carrier tube 2610, the pushertube 2620, the cover tube 2630, and the splitter tube 2680 each advancedistally and approach the first predetermined position. The tubes in thetube set 2605 can be decoupled at any time so that any of which can bemoved and positioned independently.

Upon reaching the first predetermined position, the tube set 2605 can bedisposed substantially adjacent to the outer surface 620 a of the bloodvessel wall 620 and adjacent to the opening 610 such that the splitter2070 and blood vessel wall 620 are disposed substantially between theexpanded distal region 2210 b of the locator assembly 2200 and the tubeset 2605. The cover member 2630 and the splitter tube 2680 can eachdecouple from the carrier tube 2610 and the pusher tube 2620. Thereby,the cover tube 2630 can be inhibited from further axial movement andremain substantially stationary as the carrier tube 2610 and the pushertube 2620 each remain coupled and axially slidable. Additionally, thesplitter tube 2680 can be moved independently or with the carrier tube2610 until placement adjacent to the vessel wall 620.

When the tube set 2605 is in the second predetermined position, thecarrier tube 2610 can decouple from the pusher tube 2620. As such, thecarrier tube 2610 can be advanced toward the splitter 2070 so that theproximal end 2070 a of the splitter enters the lumen 2614 (FIG. 22B) ofthe carrier tube 2610. After the carrier tube 2610 engages with thesplitter 2070, opposing movement by either element can cause the carriertube 2610 to split. For example, moving the splitter tube 2680 orsplitter 2070 proximally with respect to the carrier tube 2610 can causethe distal end 2610 b of the carrier tube 2610 to move up a splittingface 2074 of the splitter 2070. Alternatively, moving the carrier tube2610 distally towards the splitter tube 2680 or splitter 2070 can alsocause the distal end 2610 b of the carrier tube 2610 to move up thesplitting face 2074. In some instances, such as when the splitter 2070cooperates with the locator assembly 2200 to hold the vessel wall 620,the carrier tube 2610 can be configured to move distally with respect tothe splitter tube 2680 or splitter 2070. In other instances, such aswhen the carrier tube 2610 is at a maximum distal location, the splittertube 2680 can be moved proximally with respect to the carrier tube 2610.

Accordingly, the carrier tube 2610 can be split by the splitter 2070 sothat the split distal end 2610 b of the carrier tube 2610 expandsradially or bends outwardly around the splitter 2070. This can be by thecarrier tube 2610 having slits 2052 (FIG. 22B) that can separate alongthe lumen 2614 as the carrier tube 2610 is advanced over the splitter2070. For example, when the carrier tube 2610 is advanced over thesplitter 2070, the carrier tube 2610 can split and separate so as toform carrier flaps 2054. The carrier flaps 2054 can then carry theclosure element 2500 for delivery to the blood vessel wall 620.

As shown in FIG. 31B, the pusher tube 2620 can engage with the closureelement 2500 for delivery. After the carrier tube 2610 is split aroundthe splitter 2070, the pusher tube 2620 can be pushed distally so thatthe distal end region 2620 b contacts and pushes the substantiallytubular closure element 2500. As such, the pusher tube 2620 can displacethe substantially tubular closure element 2500 from the space 2660 andtoward the blood vessel wall 620. The pusher tube 2620 can direct thesubstantially tubular closure element 2500 over the distally-increasingcross-section of the split distal end region 2610 b of thesubstantially-stationary carrier member 2610 and over the splitter 2070such that the cross-section (shown in FIGS. 6A-6G) of the substantiallytubular closure element 2500 begins to radially expand in asubstantially uniform manner. As the substantially tubular closureelement 2500 traverses the distally-increasing cross-section of thedistal end region 2610 b and the splitter 2070, the cross-section of thesubstantially tubular closure element 2500 radially expands beyond thenatural cross-section (shown in FIGS. 6A-6G) of the closure element2500. This allows the tines 2520 to project in a more outward directionwhile being advanced past the splitter 2070. After passing the splitter2070 and moving distal with respect thereto, the tines 2520 can thenpenetrate the blood vessel wall 620 and contract inwards, as describedabove in connection to other embodiments. Optionally, the pusher tube2620 can split as shown in FIG. 22C so as to expand around the splitter2070 and facilitate deployment of the closure element 2500.

Referring now to FIGS. 32A-32D, methods of using a guidewire splitter2004 in accordance with the present invention will be described. Theguidewire splitter 2004 can be used in conjunction with the carrierassembly 2000 depicted and described in connection with FIGS. 21A-21E.

Referring now to FIG. 32A, there is shown a vessel 600 disposed below apatient's tissue 630 and skin 650, wherein a guidewire 2010 is disposedthrough an opening 610 formed in the vessel 620 and tissue 630 asdescribed above such that a splitter 2430 coupled to the guidewire 2010is located within the vessel 600. The guidewire 2010 having a splitter2430 may be introduced into the blood vessel for the sole purpose ofusing a splitter 2430 with the carrier assembly 2000 to deploy theclosure element 2500. Alternatively, the guidewire 2010 having thesplitter 2430 may have already been present from a previously completedinterventional procedure. That is, the guidewire splitter 2004 can beadapted to be used in place of a standard guidewire.

Referring now to FIG. 32B, the guidewire 2010 is shown to be retractedfrom the vessel 600 so that the splitter 2430 interacts with the innerwall 620 b of the vessel 600. As such, the splitter 2430 can beconfigured as a tissue-grabbing splitter by having a plurality of barbs2432 disposed thereon (see, FIG. 27B). Accordingly, as the splitter 2430is advanced toward the opening 610 in the vessel 600, the barbs 2432 cangather tissue from the inner wall 620 b of the vessel 600, and pull suchtissue toward the opening 610. After the splitter 2430 has grabbed andpulled some tissue toward the opening 610, the splitter 2430 can be usedsubstantially similar as a locator assembly. Briefly, the splitter 2430can be pulled taut by pulling the guidewire 2010, which can be usefulfor aiding in deploying the closure element as described herein.

Referring now to FIG. 32C, the tube set 2305 can be positioned adjacentto the outer wall 620 a of the blood vessel 600 as described herein.Briefly, the tube set 2305 can be moved distally down the guidewire 2010toward the vessel 600. Upon reaching a first predetermined position, thetube set 2305 can be disposed substantially adjacent to the outersurface 620 a of the blood vessel wall 620 and adjacent to the opening610 such that a proximal end 2430 a of the splitter 2430 can be disposedbetween the blood vessel wall 620 and the tube set 2305. The covermember 2330 and the support tube 2340 can each decouple from the carriertube 2310 and the pusher tube 2320. Thereby, the cover tube 2330 andsupport tube 2340 can be inhibited from further axial movement andremain substantially stationary as the carrier tube 2310 and the pushertube 2320 each remain coupled and axially slidable.

When the tube set 2305 is in a second predetermined position, carriertube 2310 can decouple from the pusher tube 2320. As such, the carriertube 2310 can be advanced toward the splitter 2430 so that the proximalend 2430 a of the splitter 2430 enters the lumen 2314 (FIG. 21B) of thecarrier tube 2310. After the carrier tube 2310 engages with the splitter2430, opposing movement by either element can cause the carrier tube2310 to split. For example, pulling the splitter 2430 proximally withrespect to the carrier tube 2310 can cause the distal end 2310 b of thecarrier tube 2310 to be split by the barbs 2432 or the splitting face2434. Alternatively, moving the carrier tube 2310 distally towards thesplitter 2430, which is held taut, can also cause the distal end 2310 bof the carrier tube 2310 to split and move up the splitting face 2434.

Accordingly, the carrier tube 2310 can be split by the splitter 2430 sothat the split distal end 2310 b of the carrier tube 2310 expandsradially or bends outwardly around the splitter 2430. This can be byslits 2022 (FIG. 21B) that can separate along the lumen 2314 as thecarrier tube 2310 is advanced over the splitter 2430. For example, whenthe carrier tube 2310 is advanced over the splitter 2430, the carriertube 2310 can split and separate so as to form carrier flaps 2024. Thecarrier flaps 2024 can then carry the closure element 2500 over thesplitter 2430 for delivery to the blood vessel wall 620.

Additionally, the pusher tube 2320 can engage with the closure element2500 for delivery. After the carrier tube 2310 is split around thesplitter 2430, the pusher tube 2320 can be pushed distally so that thedistal end region 2320 b contacts the tubular closure element 2500. Assuch, the pusher tube 2320 can displace the tubular closure element 2500from the space 2360 and toward the blood vessel wall 620. To facilitatedelivery of the closure element 2500, the pusher tube 2320 can splitwhile moving over the carrier flaps 2024 of the carrier tube 2310. Sincethe space 2360 is substantially radially exposed, the pusher tube 2320can direct the tubular closure element 2500 over the splitdistally-increasing cross-section of the split distal end region 2310 bof the substantially-stationary carrier member 2310 and over thesplitter 2430 such that the cross-section (shown in FIGS. 6A-6G) of thetubular closure element 2500 begins to radially expand in asubstantially uniform manner. As the tubular closure element 2500traverses the split distally-increasing cross-section of the distal endregion 2310 b and the splitter 2430, the cross-section of the tubularclosure element 2500 radially expands beyond the natural cross-section(shown in FIGS. 6A-6G) of the closure element 2500. This allows thetines 2520 to project in a more outward direction while being advancedover the splitter 2430. After passing the splitter 2430 and movingdistal with respect thereto, the tines 2520 can then penetrate the bloodvessel wall 620 and contract inwards, as described above in connectionto other embodiments.

Upon being directed over the distally-increasing cross-section of thedistal end region 2310 b by the pusher member 2320, the tubular closureelement 2500 can be distally deployed. When the tubular closure element2500 is deployed, the tines 2520 can pierce and otherwise engage asignificant amount of the blood vessel wall 620 and/or tissue 630adjacent to the opening 610. For example, the tines 2520 can engage asignificant amount of the blood vessel wall 620 and/or tissue 630because the cross-section of the tubular closure element 2500 isexpanded beyond the natural cross-section of the closure element 2500during deployment.

Turning to FIG. 32D, as the closure element 2500 is being deployed intothe tissue of the vessel 600, the splitter 2430 can be pulled throughthe opening 610 and out of the vessel 600. As this occurs, the tissueheld by the barbs 2432 can be pulled inwardly so that the tines 2520 ofthe closure element can penetrate the tissue further away from theopening 610. Since the cross-section of the tubular closure element 2500is expanded beyond the natural cross-section of the closure element 2500and the splitter 2430 has pulled tissue toward the opening, asignificant amount of the blood vessel wall 620 and/or tissue can bedrawn into the channel 2540 of the closure element 2500 and engaged bythe tines 2520. The tines 2520 cause the closure element 2500 to revertto a substantially planar and deployed orientation. This can occursubstantially simultaneously, before, or after the splitter 2430 ispulled from the opening 610.

Accordingly, closure element 2500, once deployed, transitions from thetubular orientation, returning to the natural, planar orientation withopposing tines 2520 and a natural cross-section of the closure element2500. The closure element 2500 substantially uniformly transitions fromthe tubular configuration to the natural, planar orientation. Rotatingaxially inwardly, the tines 2520 draw the tissue into the channel 2540as the closure element 2500 closes the opening 610. Thereby, the opening610 in the blood vessel wall 620 can be drawn substantially closedand/or sealed via the closure element 2500 as illustrated. Also, afterthe closure element 2500 has been deployed into the vessel 600, thesplitter 2430 can be retracted along with the tube set 2305.

Another alternative embodiment of a clip applier for sealing openingsthrough tissue is shown in FIGS. 33A-43D. The embodiment of FIGS.33A-43D, as described below, has many identical and/or similarstructures that perform identical and/or similar functions to theembodiments described above and in reference to the preceding Figures,and associated configurations of inventions. Accordingly, thedescription below should be considered in view of the descriptions aboveof the preceding embodiments. Furthermore, those of ordinary skill inthe art will appreciate that one or more of the components, functionsand/or features of the embodiment shown in FIGS. 33A-43D may also beincorporated in the previously described embodiments, as thosecomponents, functions, and/or features of the previously describedembodiments may optionally be incorporated in the embodiment describedbelow and in reference to FIGS. 33A-43D.

Generally, a clip applier in accordance with the present invention caninclude a clip disposed therein for delivery to a tissue surrounding anopening in the tissue. The clip, which can also be referred to as aclosure element, can be any type of clip that can be used to close anopening in a tissue as described herein or well known in the art. In oneconfiguration, the clip can have a relaxed orientation that issubstantially annular or a curved variation thereof. Also, the clip canhave a retaining and deploying configuration that is substantiallytubular and/or offset. The clip can be made of various materials, whichcan include, but not limited to, metals, plastics, ceramics,biodegradable materials, bioreabsorbable materials, shape memorymaterials, combinations thereof, and/or other materials that provide thedesired characteristics of properties of the described clip. Optionally,the clip can be heat set so as to have any of the configurationsdescribed herein, which can include offset or curved configurations soas to conform with the tubular shape of the external wall of a bloodvessel when deployed and relaxed. Additionally, examples of clips can bereviewed in the incorporated references.

FIGS. 33A-33B illustrate an embodiment of a clip 3500 a in a relaxedconfiguration in accordance with the present invention. As shown in FIG.33A, the clip 3500 a can include a body 3502 that defines centralaperture 3504. Additionally, the body 3502 can include tines 3520 thatare interconnected by struts 3508 and elbows 3510. The struts 3508 a-band elbows 3510 provide structural flexibility that allows the elbow3510 to bend so that adjacent struts 3508 a-b can move with respect toeach other. Also, each tine 3520 can include a tip 3522 that isconfigured for penetrating and/or grabbing tissue. As such, oppositelydisposed tines 3520 a-b can be positioned so that tissue on oppositesides of a hole can be grabbed and/or pulled together as tine 3520 a isdrawn inwardly toward tine 3520 b. It will be understood, however, thattine 3520 b can move toward tine 3520 a or a combination of movement ofboth tines 3520 a-b can also operate to grab, pull, or otherwise closethe opening in the tissue.

As shown in FIG. 33B, the clip 3500 a in the relaxed configuration has alongitudinal profile 3540 that is substantially planar; however, theprofile can be bent or curved so as to conform to a blood vessel asdescribed below. Also, the clip 3500 a in the relaxed configuration canhave a dimension 3530 extending from a first body side 3502 a to asecond body side 3502 b. The dimension 3530 can be modulated bystretching or compressing the clip 3500 a; however, the dimension 3530can be substantially the same when the clip 3500 a is in the relaxedorientation before being inserted into a clip applier and after beingapplied to tissue in order to close an opening or hole in the tissue.That is, the clip 3500 a can revert to having the relaxed dimension 3530after being applied to close an opening or hole in a tissue. The clip3500 a can be heat set into any of a variety of relaxed shapes that theclip can return to after being deployed, such as being substantiallyplanar, bent, curved, or offset.

FIGS. 34A-34B illustrate the clip 3500 a of FIGS. 33A-33B; however, theclip 3500 b is in a deploying configuration such as when being deployedfrom a clip applier. As shown in FIG. 34A, the elbows 3510 are bent suchthat the struts 3508 a-b, tines 3520, and tips 3522 are substantiallyaligned with the body 3502. As such, the tines 3520 a-b are no longerdirected inwardly toward the aperture 3504, which opens the aperture3504 to have a larger orthogonal cross-sectional profile. Accordingly,the clip 3500 b in the deploying configuration positions the body 3502to have an orthogonal cross-sectional profile that is substantially moreannular or ring-like compared to the relaxed configuration. The clip3500 a can be heat set in a relaxed configuration different from thedeploying configuration so that the clip passes from the deployingconfiguration to the relaxed configuration after being deployed into ablood vessel.

As shown in FIG. 34B, the clip 3500 b in the deploying configurationpositions the body 3502 so as to have a longitudinal profile 3542 thatis substantially rectangular or tubular, which can be substantially notoffset. That is, the clip 3500 b has a central axis 3560 within theaperture 3504, and the body 3502 forms a tube therearound such that theaperture 3504 is a lumen of the tube that has an even or symmetricalprofile. The tubular shape is formed by bending the tines 3520 frompointing inwardly, as in the relaxed configuration, to pointingsubstantially longitudinally and distally in the deployingconfiguration. Accordingly, the tines 3520 project from a proximal end3552 of the clip 3500 b toward a distal end 3550, which positions thetips 3522 to be at the distal end 3550. Additionally, when the clip 3500b is in the deploying configuration, the tines 3520 a-b and tips 3522are positioned substantially even with each other so that a line 3562from any of the tines 3520 a-b or tips 3522 is orthogonal with respectto the central axis 3560. As such, the line 3562 forms an angle α withthe central axis 3560, wherein the angle α is substantially 90 degreeswhen the clip 3500 b is in the deploying configuration. This can be seenby tine 3520 a being substantially even with tine 3520 b. Althoughreference is made to the angular orientation of line 3562 and centralaxis 3560, one skilled in the art would understand that the angularorientation of less than or greater than substantially 90 degrees ispossible.

Also, the clip 3500 b in the deploying configuration has a dimension3532 extending from a first tine 3520 a to a second tine 3520 b. Thedimension 3532 can be modulated by stretching or compressing the clip3500 b; however, the dimension 3532 can be substantially the same ordifferent compared to instances when the clip 3500 a is in the relaxedconfiguration.

FIGS. 35A-35B illustrate the clip 3500 a of FIGS. 33A-33B; however, theclip 3500 c is in a retaining configuration such as when being retainedwithin a clip applier. As shown in FIG. 35A, the elbows 3510 are bentsuch that the struts 3508 a-b, tines 3520, and tips 3522 aresubstantially aligned with the body 3502. As such, the tines 3520 a-bare no longer directed inwardly toward the aperture 3504, which opensthe aperture 3504 to have a larger orthogonal cross-sectional profilecompared to the clip 3500 a in the relaxed configuration. Accordingly,the clip 3500 c in the retaining configuration can position the body3502 to have an orthogonal cross-sectional profile that is substantiallymore annular or ring-like compared to the relaxed configuration. Theorthogonal cross-sectional profile of the body 3502 in the retainingconfiguration can be smaller in at least one dimension compared to thedeploying configuration.

As shown in FIG. 35B, the clip 3500 c in the retaining configurationpositions the body 3502 so as to have a longitudinal profile 3544 thatis substantially an offset parallelogram or tubular. That is, the clip3500 c has a central axis 3560 within the aperture 3504, and the body3502 forms an offset tube therearound such that the aperture 3504 is alumen of the tube. The offset tubular shape (e.g., retainingconfiguration) can be formed by bending the tines 3520 from pointinginwardly, as in the relaxed configuration, to pointing substantiallylongitudinally and distally, as in the deploying configuration, and thenlongitudinally and distally stretching a first tine 3520 a compared to asecond tine 3520 b. Accordingly, the first tine 3520 a projects from aproximal end 3552 of the clip 3500 c toward a distal end 3550 so as tobe more distally located compared to the second tine 3520 b. As such,the tip 3522 a of the first tine 3520 a can be positioned more distallycompared to the tip 3522 b of the second tine 3520 b. Additionally, whenthe clip 3500 c is in the retaining configuration, the tines 3520 a-band tips 3522 a-b can be offset from each other. That is, the first tine3520 a and tip 3522 a can be positioned more distally, and the secondtine 3520 b and tip 3522 b can be positioned more proximally. As such, aline 3562 from any of the tines 3520 a-b or tips 3522 can be offset withrespect to the central axis 3560. As such, the line 3562 can form anangle γ with the central axis 3560, wherein the angle γ can besubstantially less than 90 degrees when the clip 3500 c is in theretaining configuration. This can be seen by tine 3520 a beingsubstantially offset with respect to tine 3520 b. The clip 3500 c in theretaining configuration can have various angular orientations. In thismanner, the outside diameter of the clip can be reduced and so theoutside diameter of the clip applier used to deploy the clip can also bereduced. In one configuration, the angle γ can be about 20 to about 70degrees. In another configuration, the angle γ can be about 30 to about60 degrees. In still another configuration, the angle γ can be about 50degrees or about 45 degrees.

Optionally, the retaining configuration as described herein can also bethe deploying configuration described in connection to FIGS. 33A-33B.That is, a clip 3500 c in the retaining configuration can revert to therelaxed configuration without passing through the symmetrical, tubulardeploying configuration of FIGS. 33A-33B, and can retain some of theoffset character. As such, the clip 3500 c can be heat set in aconfiguration similarly as shown in FIG. 33A with the exception the body3502 is offset at an angle γ from the axis 3560, which allows theretaining configuration to also be in an offset deploying configuration.

With continued reference to FIG. 35B, the clip 3500 c in the retainingconfiguration can have a dimension 3534 extending from a first tine 3520a to a second tine 3520 b. The dimension 3534 can be modulated bystretching or compressing the clip 3500 c; however, the dimension 3534can be smaller compared to when the clip 3500 a is in the relaxedconfiguration or when the clip 3500 b is in the deploying configuration.As such, the dimension 3534 can be narrowed when retained within a clipapplier so that the dimensions of the clip applier can be similarlyreduced. Thus, longitudinally stretching a first tine 3520 a away fromthe opposite second tine 3520 b can facilitate the clip 3500 c to have asmaller orthogonal cross-sectional profile in at least one dimension.

FIG. 36A is a schematic representation of the change in dimensions whena clip 3500 b in the deploying configuration is longitudinally stretchedat opposing tines 3520 a-b into the clip 3500 c in the retainingconfiguration. While the body 3502 of the clip 3500 b is shown to beinggenerally circular, the tines, struts, and elbows can skew portions ofthe body 3502. As such, the generally circular depiction is merely forconvenience and simplicity. The body 3502 of the clip 3500 b in thedeploying configuration can have an outer dimension 3570, and can definean aperture 3504 a that has an orthogonal cross-sectional profile withat least one inner dimension 3572. Additionally, it can be seen that thedistance between the first tine 3520 a and the second tine 3520 b can besubstantially the same as the inner dimension 3572 of the aperture 3504a.

After the clip 3500 b in the deploying configuration is stretched intothe clip 3500 c in the retaining configuration, some of the dimensionschange. As such, the body 3502 of the clip 3500 c in the retainingconfiguration can have an outer dimension 3574 that is smaller than theouter dimension 3570 when the clip 3500 b is in the deployingconfiguration. Additionally, the aperture 3504 b defined by the body3502 of the clip 3500 c in the retaining configuration can have an innerdimension 3576 that is smaller than the dimension 3572 of the aperture3504 a of the clip 3500 b in the deploying configuration. The distancebetween the first tine 3520 a and the second tine 3520 b can besubstantially the same as the inner dimension 3576. The reduced outerdimension 3574 and the inner dimension 3576 of the clip 3500 c in theretaining configuration can be achieved by longitudinally and distallystretching the first tine 3520 a away from the second tine 3520 b and/orlongitudinally and proximally stretching the second tine 3520 b awayfrom the first tine 3520 a. Moreover, the aperture 3504 a of the clip3500 b in the deploying configuration and of the clip 3500 c in theretaining configuration can be generally circular. This allows a tube inthe clip applier assembly to be generally circular so that the clip 3500c can be retained therein and deployed therefrom.

Additionally, the clip 3500 c can be heat set in a manner that resultsin the body having the offset orientation shown in FIG. 36A such thatthe clip 3500 c does not revert to a symmetrical deploying configurationas shown by clip 3500 b. That is, the clip 3500 b can be stretched to beoffset before the tines 3520 are extended (e.g., while still pointinginwardly toward the aperture 3504), which allows the clip 3500 b toretract to an offset relaxed configuration.

FIG. 36B is another schematic representation of the change in dimensionswhen a clip 3500 b in the deploying configuration is longitudinallystretched at opposing tines 3520 a-b into the clip 3500 d in a generallyoval retaining configuration. As before, while the body 3502 of the clip3500 b is shown to be generally circular, the tines, struts, and elbowscan skew portions of the body 3502. The body 3502 of the clip 3500 b inthe deploying configuration can have an outer dimension 3580, and candefine an aperture 3504 a that has an orthogonal cross-sectional profilethat is generally circular with a first inner dimension 3578 that issubstantially the same as an orthogonal second inner dimension 3578.Additionally, it can be seen that the distance between the first tine3520 a and the second tine 3520 b can be substantially the same as theinner dimension 3578 of the aperture 3504 a.

After the clip 3500 b in the deploying configuration is stretched intothe clip 3500 d in the generally oval retaining configuration, some ofthe dimensions can change. As such, the body 3502 of the clip 3500 d inthe generally oval retaining configuration can have an outer dimension3584 that is smaller than the outer dimension 3580 when the clip 3500 bis in the deploying configuration. Additionally, the aperture 3504 cdefined by the body 3502 of the clip 3500 d in the generally ovalretaining configuration can have a first inner dimension 3582 that issmaller than the first inner dimension 3578 of the aperture 3504 a ofthe clip 3500 b in the deploying configuration. Also, the aperture 3504c defined by the body 3502 of the clip 3500 d in the generally ovalretaining configuration can have a second inner dimension 3578substantially the same as the second inner dimension 3578 of theaperture 3504 a of the clip 3500 b in the deploying configuration. Thedistance 3586 between the first tine 3520 a and the second tine 3520 bcan be substantially the same as the smaller first inner dimension 3582of the clip 3500 d in the generally oval retaining configuration. Thereduced outer dimension 3584 and the reduced inner dimension 3582 of theclip 3500 d in the generally oval retaining configuration can beachieved by longitudinally and distally stretching the first tine 3520 afrom the second tine 3520 b and/or longitudinally and proximallystretching the second tine 3520 b from the first tine 3520 a. Moreover,the aperture 3504 c of the clip 3500 d in the generally oval retainingconfiguration can be generally oval and narrower in one dimensioncompared to an orthogonal second dimension. This allows a tube in theclip applier assembly to be generally oval so that the clip 3500 d canbe retained therein and deployed therefrom.

Additionally, the clip 3500 d can be heat set in a manner that resultsin the body having an oval and offset orientation shown in FIG. 36B suchthat the clip 3500 d does not revert to a symmetrical deployingconfiguration as shown by clip 3500 b. That is, the clip 3500 d can bestretched to be oval and offset before the tines 3520 are extended(e.g., while still pointing inwardly toward the aperture 3504), whichallows the clip 3500 b to retract to an oval and offset relaxedconfiguration.

Additionally, a clip in accordance with the present invention can bereduced in size compared to previous clips. In addition to reducing thesize of each component of a clip, the number of tines, struts, andelbows can be reduced so that the overall size of the clip can besmaller. For example, the clip can be configured to have two or moretines, and corresponding struts and elbows. Also, the clip can have areduced number of tines, struts, and/or elbows so that the tines areoffset, which can provide a clip having an odd number of tines.

As shown in FIG. 37A, the clip 3500 e can be heat set in the relaxedconfiguration that has a curved longitudinal profile, which can bedimensioned to conform to the shape of an external wall of a bloodvessel. Also, the clip 3500 e in the curved relaxed configuration canhave a dimension 3530 e that defines the length of the body 3502 e. Thedimension 3530 e can be modulated by stretching or compressing the clip3500 e or by changing the angle of the curve; however, the dimension3530 e can be substantially the same when the clip 3500 e is in thecurved relaxed orientation before being inserted into a clip applier andafter being applied to tissue in order to close an opening or hole inthe tissue. That is, the clip 3500 e can revert to having the curvedrelaxed dimension 3530 e after being applied to close an opening or holein a tissue so that the clip 3500 e has a similar shape as the bloodvessel. The clip 3500 e can be heat set so that the tines 3520 e, whichare shown by the dashed lines within the body 3502 e, follow the contouror curve of the body 3520 e.

As shown in FIG. 37B, the clip 3500 f can be heat set in the relaxedconfiguration that has a curved “C” shaped longitudinal profile, whichcan be dimensioned to conform to the shape of an external wall of ablood vessel. Also, the clip 3500 f in the “C” relaxed configuration canhave a dimension 3530 e that defines the length of the body 3502 f. Thedimension 3530 e can be modulated by stretching or compressing the clip3500 f or by changing the angle of the “C” shaped curve; however, thedimension 3530 f can be substantially the same when the clip 3500 f isin the curved relaxed orientation before being inserted into a clipapplier and after being applied to tissue in order to close an openingor hole in the tissue. That is, the clip 3500 f can revert to having the“C” shaped relaxed dimension 3530 f after being applied to close anopening or hole in a tissue so that the clip 3500 f has a similar shapeas the blood vessel. The clip 3500 f can be heat set so that the tines3520 f point inwardly so as to aid in forming the “C” shape as shown.

FIG. 37C illustrates an embodiment of a clip 3500 g in a retaining anddeploying orientation that has been heat set in and reverts to an offsetrelaxed configuration as shown by 3500 h so that the tines 3520 do notpoint towards each other. As shown, the retaining and deployingconfiguration of the clip 3500 g has the body 3502 g in an offset orangled orientation with respect to the tines 3520 g such that whenreleased, the tines 3520 g return to being inwardly pointing tines 3520h while the body 3502 h retains the offset or angled shape. That is, thebody 3502 h in the relaxed configuration is offset so as to besubstantially the same as the body 3502 g in the retaining and deployingconfiguration. Also, the tines 3520 h are offset so that they do notpoint inwardly to the same point, which allows the inwardly pointingtines 3520 h to grab different sections of tissue to be pulled towardthe body 3502 h in different distances so that one tine 3520 h is moredistal compared to a substantially opposite tine 3520 h.

FIG. 37D illustrates an embodiment of a clip 3500 i in a retaining anddeploying orientation that has been heat set in and reverts to an offsetrelaxed configuration as shown by 3500 j so that the tines 3520 j pointtowards each other. As shown, the retaining and deploying configurationof the clip 3500 i has the body 3502 i in an offset or angledorientation with respect to the tines 3520 i such that when released,the tines 3520 i return to being inwardly pointing tines 3520 j thatpoint towards each other while the body 3502 j retains the offset orangled shape. That is, the body 3502 j in the relaxed configuration isoffset so as to be substantially the same as the body 3502 i in theretaining and deploying configuration.

Also, the outer dimension of a clip in the symmetrical, tubularretaining and/or deploying configuration when the clip is at about 90degrees with respect to a central axis can be about 0.17 inch. However,the same clip in the offset or angled retaining and/or deployingorientation when the clip is at about 45 degrees with respect to thecentral axis can have the outer diameter reduced to about 0.12 inch.Accordingly, this can correspond with a clip at about 90 degrees withrespect to the central axis having a circumference of about 13.56 mm,which is commonly referred to as 13 F, and the clip at about 45 degreeswith respect to the central axis can have a circumference of 1.56 mm,which is commonly referred to as 11 F. Accordingly, a clip in aretaining configuration can have a smaller dimension as well as asmaller circumference when having a generally circular orthogonalcross-sectional profile or a generally oval orthogonal cross-sectionalprofile. Also, the orthogonal cross-sectional profile can be fixed, suchas by heat setting, as oval, square, rectangular or other shape so thatthe clip is substantially devoid of reverting to a circular shape whenrelaxed, and stays in the heat set shape when relaxed. It will beunderstood that the above-described angular orientations and dimensionsare only illustrative of certain configurations of the clip of thepresently described invention. It will be understood that other angularorientations and dimensions are possible.

Turning to FIGS. 38A-38F, the carrier assembly 3000 can include a tubeset 3305, including a carrier tube 3310, a pusher tube 3320, a supporttube 3340, and a cover tube 3330. The carrier tube 3310, the pusher tube3320, the support tube 3340, and the cover tube 3330 can be provided asa plurality of nested, telescoping tubes with a common longitudinal axis3350 as illustrated in FIG. 38A. While the carrier assembly 3000 isdescribed as including a tube set 3305, such tubes can be exchanged withother members with substantially similar functionalities as describedherein. The carrier tube 3310 can be configured to receive and supportthe clip 3500 in an offset orientation (e.g., retaining configuration).While being disposed on the carrier tube 3310, the clip 3500 can bedeformed from the natural, planar orientation (e.g., relaxedconfiguration) and selectively stretched to form the substantiallyoffset-tubular shape (e.g., retaining configuration, which is shown inFIGS. 35A-35B). Being disposed substantially about and supported by anouter periphery 3312 of the carrier tube 3310, the substantiallyoffset-tubular clip 3500 can be substantially in axial alignment withthe carrier tube 3310 with the tines 3520 pointed substantially distallyand parallel with the tube set 3305. Thus, the first tine 3520 a beingmore distally disposed compared to the second tine 3520 b.

As shown in FIG. 38B, the carrier tube 3310 can have a proximal endregion 3310 a and a distal end region 3310 b. Also, the carrier tube3310 can include a predetermined length 3318 a, a predetermined outerdiameter 3318 b, and a predetermined inner diameter 3318 c, any of whichcan be of any suitable dimension. In one configuration, the carrier tube3310 can be formed as a substantially rigid, semi-rigid, or flexibletubular member; however, other suitable configurations can also beemployed. However, the carrier tube 3310 can be a selectively expandablecarrier as described in more detail below. The carrier tube 3310 candefine a lumen 3314 that extends substantially between the proximal endregion 3310 a and the distal end region 3310 b, and can be configured toslide relative to the other tubes in the tube set 3305. The carrier tube3310 can have a distal end 3014 that is optionally tapered from a firstportion 3014 a to a second portion 3014 b, which allows for releasingthe clip 3500 in the substantially offset-tubular orientation.Alternatively, the distal end 3014 can be blunt as described inconnection with other embodiments. Additionally, the carrier tube 3310can include a body 3311 that is configured to radially expand.

The orthogonal cross-sectional profile of the carrier tube 3310 can begenerally circular or generally oval, which can correspond to theorthogonal cross-sectional profile of the clip 3500 in the retainingconfiguration, but can alternatively have configurations other thangenerally circular or generally oval while still receiving the clip3500. Also, the outer diameter 3318 b of the carrier tube 3310 can besubstantially uniform such that the distal end region 3310 b of thecarrier tube 3310 has an orthogonal cross-section similar to theproximal end region 3310 a. However, it may be beneficial for the distalend region 3310 b to be expandable or configured in such a way that theouter diameter 3318 b can selectively expand or bend outwardly so thatthe closure element 3500 and/or tines 3520 can be outwardly oriented.This can include expanding at least the distal end of the offset-tubularclosure element 3500 beyond the natural cross-section when beingdeployed; however, the entire closure element 3500 can be expanded withthe distal end being expanded before the proximal end.

As shown in FIG. 38C, the clip 3500 can be disposed on the carrier tube3310 in an offset tubular orientation (e.g., retaining configuration).As such, the elbows 3510 can be stretched so that the struts 3508 areseparated away from each other. This allows for the first tine 3520 aand first tip 3522 a to be more distally oriented with respect to thesecond tine 3520 b and second tip 3522 b.

As shown in FIG. 38D, the pusher tube 3320 can be configured to distallypush and/or deploy the substantially offset-tubular clip 3500. As such,the pusher tube 3320 can have a proximal end region 3320 a and a distalend region 3320 b and can be coupled with, and slidable relative to, thecarrier tube 3310. The pusher tube 3320 can include a predeterminedlength 3328 a, a predetermined outer diameter 3328 b, and apredetermined inner diameter 3328 c, any of which can be of any suitabledimension. The pusher tube 3320 can be configured to slidably receivethe carrier tube 3310 such that the distal end region 3320 b of thepusher tube 3320 can be offset proximally from the distal end region3310 b of the carrier tube 3310. As desired, the predetermined length3328 a of the pusher tube 3320 can be greater than or substantiallyequal to the predetermined length 3318 a of the carrier tube 3310. Thepusher tube 3320 can be positioned in the tube set 3305 with respect tothe carrier tube 3310 such that the carrier tube 3310 and the pushertube 3320 at least partially define a space 3360 distal to the distalend region 3320 b of the pusher tube 3320 and along the periphery 3312of the carrier tube 3310. The space 3360 can be configured for housingor containing the offset-tubular clip 3500.

The pusher tube 3320 can be formed from a substantially rigid,semi-rigid, or flexible material. Also, the pusher tube 3320 can besubstantially tubular and have a body 3321 defining a lumen 3324 thatextends substantially between the proximal end region 3320 a and thedistal end region 3320 b. The pusher tube 3320 can be configured toslidably receive at least a portion of the carrier tube 3310 so that theinner diameter 3328 c of the pusher tube 3320 is equal to or larger thanthe outer diameter 3318 b of the carrier tube 3310. The outer diameter3328 b and/or inner diameter 3328 c of the pusher tube 3320 can besubstantially uniform, and have a complementary cross-sectional profileto that of the carrier tube 3310 and/or the clip 3500. For example, whenthe carrier tube 3310 and/or the clip 3500 have orthogonalcross-sectional profiles that are either generally circular or generallyoval, the outer diameter 3328 b and/or inner diameter 3328 c of thepusher tube 3320 can be either generally circular or generally oval.

Also, the distal end region 3320 b of the pusher tube 3320 can includeone or more longitudinal extensions 3325, which extend distally from thepusher tube 3320 and along the periphery 3312 of the carrier tube. Thelongitudinal extensions 3325 can be configured to push the clip 3500during deployment. As such, the longitudinal extensions can include afirst extension 3325 a, a second extension 3325 b, and a third extension3325 c, where the first extension 3325 a is more distally disposedcompared to the second extension 3325 b that is more distally disposedcompared to the third extension 3325 c. Accordingly, the extensions 3325a-c can be offset so as to facilitate deployment of an offset-tubularclip 3500. Alternatively, the extensions 3325 a-c can be blunt asdescribed in connection with other embodiments. The longitudinalextensions 3325 a-c can be biased such that the longitudinal extensions3325 a-c extend generally in parallel with a common longitudinal axis3350. The longitudinal extensions 3325 a-c can be sufficiently flexibleto expand radially or bend outwardly, and yet sufficiently rigid toinhibit buckling, as the distal end region 3320 b is directed distallyalong the carrier tube 3310 and engages the substantially offset-tubularclip 3500 for deployment.

As shown in FIGS. 38A and 38E, a cover tube 3330 can be configured toretain the substantially offset-tubular clip 3500 substantially withinthe carrier assembly 3000 prior to deployment. Being coupled with, andslidable relative to, the pusher tube 3320, the cover tube 3330 can havea proximal end region 3330 a and a distal end region 3330 b. Also, thecover tube 3330 can include a predetermined length 3338 a, apredetermined outer diameter 3338 b, and a predetermined inner diameter3338 c, any of which can be of any suitable dimension.

The cover tube 3330 can be formed as a substantially rigid, semi-rigid,or flexible tubular member. Also, the cover tube 3330 can have an outerperiphery 3332 and have a body 3331 that defines a lumen 3334. The lumen3334 can extend substantially between the proximal and distal endregions 3330 a, 3330 b of the cover tube 3330, and it can be configuredto slidably receive at least a portion of the pusher tube 3320 or anymember of the tube set 3305. When the cover tube 3330 is properlypositioned with respect to the other tubes in the tube set 3305, thedistal end region 3330 b can be configured to extend over the space3360, thereby defining an annular cavity 3370 for receiving, retaining,and deploying the offset-tubular closure element 3500. The outerdiameter 3338 b and/or inner diameter 3338 c of the cover tube 3330 canbe substantially uniform along the length 3338 a, or vary in dimensionsas desired. Also, the cross-sectional profile of the cover tube 3330 canbe complementary to any of the tubes or structures of the tube set 3305and/or the clip 3500. For example, when tubes or structures of the tubeset and/or the clip are generally circular or generally oval, thecross-sectional profile of the cover tube 3330 can be generally circularor generally oval.

Additionally, the distal end region 3330 b of the cover tube 3330 caninclude one or more longitudinal extensions 3335, which extend distallyfrom the cover tube 3330 and along an outer periphery 3322 of the pushertube 3320. Although the longitudinal extensions 3335 can extendgenerally in parallel with a common longitudinal axis 3350, thelongitudinal extensions 3335 can be biased such that the plurality oflongitudinal extensions 3335 extends substantially radially inwardly.Thereby, the longitudinal extensions 3335 can at least partially closethe lumen 3334 substantially adjacent to the distal end region 3330 b ofthe cover tube 3330. To permit the substantially offset-tubular clip3500 to be deployed from the annular cavity 3370, the longitudinalextensions 3335 can be sufficiently flexible to expand or bend radiallyoutward so as to permit the distal end region 3310 b of the carrier tube3310 to move distally past the cover tube 3330 to open the annularcavity 3370 such that the distal end region 3330 b no longer extendsover the space 3360. Also, the longitudinal extensions 3335 of the covertube 3330 can be configured substantially similar to the longitudinalextensions 3325 of the pusher tube 3320.

As shown in FIGS. 38A and 38F, the tube set 3305 can include a supporttube 3340. The support tube 3340 can be configured to slidably receive awire (e.g., guidewire), locator, or the like. Also, the support tube3340 can provide radial support for the other tubes within the tube set3305. The carrier assembly 3000 can advantageously include the supporttube 3340, for example, to provide sufficient support to the carriertube 3310 in the instance it is not sufficiently rigid or under othercircumstances in which support for the carrier tube 3310 or other tubesin the tube set 3305 might be desirable. Also, the support tube 3340 canbe configured to be expandable.

The support tube 3340 can be formed as a substantially rigid,semi-rigid, or flexible tubular member, and have a proximal end region3340 a and a distal end region 3340 b. An outer periphery 3342 of thesupport tube 3340 can define a lumen 3344 that extends substantiallybetween the proximal end region 3340 a and the distal end region 3340 b.The lumen 3344 can be configured to slidably receive and support atleast a portion of a guidewire, locator, or other type of movable memberdisposed therein.

The support tube 3340, in turn, can be at least partially slidablydisposed within the lumen 3314 of the carrier tube 3310. The supporttube 3340 can have a predetermined length 3348 a, a predetermined outerdiameter 3348 b, and a predetermined inner diameter 3348 c, any of whichcan be of any suitable dimension. Also, the outer diameter 3348 b of thesupport tube 3340 can be substantially uniform and smaller than innerdiameter 3318 c of the carrier tube 3310, and the inner diameter 3348 cof the support tube 3340 can be larger than the size of the guidewire,locator, or other type of movable member disposed therein. Moreover, thesupport tube 3340 can have a cross-sectional profile that iscomplementary to other structures of the carrier assembly 3000. Forinstance, the support tube 3340 can have an orthogonal cross-sectionalprofile that is generally circular or generally oval to correspond withthe orthogonal cross-sectional profile of the carrier tube 3310 and/orthe clip 3500.

In the instance the carrier assembly 3000 is assembled as the pluralityof nested, telescoping members as shown in FIG. 38A, the carrier tube3310 can be at least partially disposed within, and slidable relativeto, the lumen 3324 of the pusher tube 3320. The pusher tube 3320, inturn, can be at least partially disposed within, and slidable relativeto, the lumen 3334 of the cover tube 3330. In the instance the carrierassembly 3000 can include a support tube 3340 as depicted, the guidewireor locator can be disposed within, and slidable relative to, the lumen3344 of the support tube 3340. Although shown and described as beingsubstantially separate for purposes of illustration, it will beappreciated that the carrier tube 3310, the pusher tube 3320, the covertube 3330, and/or the support tub 3340 can be provided, in whole or inpart, as one or more integrated assemblies. For example, the supporttube 3340 can be combined with the carrier tube 3310.

Additionally, any of the tubes in the tube set 3305 can be made ofvarious materials. While polymers or metals can be used, combinations ofmetals and polymers can also be used. For example, a tube can beprepared with nylon and reinforced with wires that run longitudinally orare spirally wrapped around the tube. Also, the tubes can be preparedfrom a shape memory material, such as nitinol. In the instance a carriertube 3310 can be made of nylon and reinforced with wire or made ofnitinol, a separate support tube may not be necessary.

A clip applier apparatus in accordance with the present invention caninclude an expandable member. An expandable member can be used in placeof any of the tubes of a tube set or in addition thereto. Also, anexpandable member can be selectively expanded so that a clip is expandedprior or during deployment, which can be beneficial for expanding theclip from a retaining configuration that has a narrow orthogonalcross-sectional profile. As such, an expandable member can be located ata distal end of the clip applier apparatus and can be selectivelyexpanded when the clip is disposed thereon and/or being deployedtherefrom.

FIGS. 39A-39B illustrate an embodiment of an expandable member 3100 thatcan be selectively expanded so that the entire expandable member or aportion thereof can be expanded. Accordingly, the expandable member 3100can be configured to be substantially tubular in shape. The expandablemember 3100 can include a plurality of annular elements 3110 a-c thatcan have a plurality of crossbars 3120 that are connected together byelbows 3130 and intersections 3140. More particularly,circumferentially-adjacent crossbars 3120 can be coupled at an elbow3130 and four or more circumferentially-adjacent crossbars 3120 can becoupled together at an intersection 3140. With this configuration,crossbars 3120, intersections 3140, and elbows 3130 can cooperate so asto form a structure 3170 that allows for flexibility as each structure3170 can expand or collapse in order for the expandable member to beselectively expanded and/or collapsed. In the illustrated configuration,the structure 3170 has a generally diamond shape that can provide theidentified flexibility to the expandable member 3100. Thus, each annularelement 3110 can have a series of circumferentially-interconnectedflexible structures 3170, such as, but not limited to, diamondstructures, that can expand or collapse under the influence of a balloonor change of temperature.

It will be understood that structure 3170 can have other configurationswhile providing the desired flexibility. For instance, structures 3170could be replaced with a repeating “V”, a repeating “U”, or otherstructures well known in the art of stents. As such, the expandablemember 3100 can be substantially similar to a stent and can have thevarious components and functionalities well known to be used in stents,which can allow for selective expansion from a collapsed orientation.Additionally, it shall be understood that the structures 3170 are sizedrelative to the clip, such that the clip can be moved relative to theexpandable member when the expandable member is in an expanded orcontracted configuration.

FIG. 39A shows the expandable member 3100 a in a collapsed orientationso that the annular elements 3110 a-c are contracted toward each other,which can be beneficial for use within a tube set of a clip applier.

FIG. 39B shows the expandable member 3100 b in a selectively expandedorientation so that the annular elements 3110 a-c are outwardlyexpanded. As shown, the first annular element 3110 a is partiallyexpanded with a first end 3112 not expanding or being expanded less thana second end 3114 so as to have a substantially conical shape.Similarly, the second annular element 3110 b and third annular element3110 c are selectively expanded with conical shapes. As such, theexpandable member 3100 b in a selectively expanded orientation can havea substantially conical shape with the proximal end 3102 being lessexpanded compared to the distal end 3104. In the instance the first end3112 of the first annular element 3110 a does not expand, the crossbars3120 or elbows 3130 at the first end 3112 can be coupled together orintegrally formed into a continuous annular end.

Additionally, an expandable member can be used as a tube in a tube set.This can include the entire tube being selectively expandable asdescribed herein, or a portion of the tube having the expandable member.For example, a support tube and/or a carrier tube can have a distalportion configured as an expandable element, which can be exemplified byeither of the tubes being coupled to an end of the expandable member.

FIGS. 40A-40B show an embodiment of a selectively expandable carriertube 3180 which can include a carrier tube 3310 coupled to an expandablemember 3100 a. As such, the selectively expandable carrier tube 3180 canhave any of the characteristics and elements described herein withrespect to a carrier tube 3310, and can have any of the characteristicsand elements described herein with respect to an expandable member 3100a. FIG. 40A shows the selectively expandable carrier tube 3180 in acollapsed orientation, and FIG. 40B shows the selectively expandablecarrier tube 3180 having the expandable member 3100 b in a selectivelyexpanded orientation. The selectively expandable carrier tube 3180 canbe characterized by a proximal end 3102 of the expandable member 3100 abeing coupled to a distal portion 3610 b of the carrier tube 3610through a coupling 3106. The coupling 3106 can hold the proximal end3102 of the expandable member 3100 a so that it does not expand. Thiscan allow for the expandable element to expand into a conical shape. Thecoupling 3106 can be achieved through a variety of different techniquesor structures. For instance and not by way of limitation, the coupling3106 can be any of the following: (a) a distal portion 3310 b of thecarrier tube 3310 overlapping the proximal end 3102 of the expandablemember 3100; (b) adhesives; (c) securing rings; (d) overlapping securitysleeve; and (e) the like.

FIG. 40C illustrates another embodiment of a selectively expandablecarrier tube 3411 which can include a carrier tube 3408 coupled to anexpandable member 3412. As such, the selectively expandable carrier tube3411 can have any of the characteristics and elements described hereinwith respect to a carrier tube, and can have any of the characteristicsand elements described herein with respect to an expandable member. Thecarrier tube 3408 includes a splittable body 3410 that can split in apredetermined pattern 3414 in order to expand as shown. Accordingly, thepredetermined pattern 3414 can include elements similar to those ofstents to provide support and allow for expansion of the closureelement.

Another alternative embodiment of a clip applier assembly can include anexpandable tube and is shown in FIGS. 41A-41F. The embodiment of FIGS.41A-41F, as described below, can have many identical or similarstructures that perform identical or similar functions to theembodiments described above and in reference to the preceding figures.Accordingly, the description below should be considered in view of thedescriptions above of the preceding embodiments. Furthermore, those ofordinary skill in the art will appreciate that one or more of thecomponents and/or features of the embodiment shown in FIGS. 41A-41F mayalso be incorporated in the previously described embodiments, as thosecomponents and/or features of the previously described embodiments mayoptionally be incorporated in the embodiment described below and inreference to FIGS. 41A-41F.

Turning to FIGS. 41A-41F, the carrier assembly 3002 can include a tubeset 3605, including a selectively expandable carrier tube 3180, a pushertube 3620, a support tube 3640, and a cover tube 3630. The expandablecarrier tube 3180, the pusher tube 3620, the support tube 3640, and thecover tube 3630 can be provided as a plurality of nested, telescopingtubes with a common longitudinal axis 3650 as illustrated in FIG. 41A.While the carrier assembly 3002 is described as including a tube set3605, such tubes can be exchanged with other members with substantiallysimilar functionalities as described herein. The expandable carrier tube3180 can be configured to receive and support the clip 3500 in anoffset-tubular orientation (e.g., retaining configuration), and canexpand the clip 3500 during deployment. While being disposed on theexpandable carrier tube 3180, the clip 3500 can be deformed from thenatural, planar orientation (e.g., relaxed configuration) andselectively stretched to form the substantially offset-tubular shape(e.g., retaining configuration, which is shown in FIGS. 35A-35B). Beingdisposed substantially about and supported by an outer periphery 3612 ofthe expandable carrier tube 3180, the substantially offset-tubular clip3500 can be substantially in axial alignment with the expandable carriertube 3180 with the tines 3520 pointed substantially distally andparallel with the tube set 3605. Thus, the first tine 3520 a being moredistally disposed compared to the second tine 3520 b.

As shown in FIG. 41B, expandable carrier tube 3180 can include a carriertube 3610 coupled to an expandable member 3100 through a coupling 3106,in an alternative embodiment, the expandable portion and the carriertube portion may be formed of a unitary member. As such, the carriertube 3610 can have a proximal end region 3610 a and a distal end region3610 b coupled to a proximal end 3102 of the expandable member 3100.Optionally, the expandable member 3100 can be held in a collapsed anddeployable orientation by a sheath 3109, wherein the sheath 3109 canform a part of the coupling. Further still, the expandable member may beexpanded by retraction of the support tube 3640, wherein an enlargeddiameter portion (not shown) is disposed on the support tube distal tothe distal end of the carrier tube. In use, the support tube movesproximal relative to the carrier tube, thereby expanding the expandableportion of the carrier tube to expand the clip. The coupling 3106 can beany of the following: (a) a distal portion 3610 b of the carrier tube3610 overlapping the proximal end 3102 of the expandable member 3100;(b) adhesives; (c) securing rings; (d) overlapping security sleeve; and(e) the like. Also, the sheath can be a part of the body 3611 of thecarrier tube 3610.

Additionally, the carrier tube 3610 can include a body 3611 that isconfigured to radially expand via expansion of the expandable member3100 as shown by the arrows. Accordingly, the expandable carrier tube3180 can include the elements of a carrier tube 3610 as described inconnection with FIG. 38B or other carrier tube described herein, and caninclude the elements of an expandable member 3100 as described inconnection with FIGS. 39A-39B. Also, the expandable carrier tube 3180can be substantially as described in connection with FIGS. 40A-40C.Moreover, the cover tube 3630, pusher tube 3620, and support tube 3640can be substantially as described in connection with FIGS. 38D-38F.

As shown in FIG. 41C, the clip 3500 can be disposed on the expandablecarrier tube 3180 in an offset tubular orientation (e.g., retainingconfiguration). As such, the elbows 3510 can be stretched so that thestruts 3508 are separated away from each other. This allows for thefirst tine 3520 a and first tip 3522 a to be more distally oriented withrespect to the second tine 3520 b and second tip 3522 b.

As shown in FIG. 41D, the pusher tube 3620 can be configured to distallypush and/or deploy the offset-tubular closure element 3500. As such, thepusher tube 3620 can have a proximal end region 3620 a and a distal endregion 3620 b and can be coupled with, and slidable relative to, theexpandable carrier tube 3180. The pusher tube 3620 can include apredetermined length 3628 a, a predetermined outer diameter 3628 b, anda predetermined inner diameter 3628 c, any of which can be of anysuitable dimension. The pusher tube 3620 can be configured to slidablyreceive the expandable carrier tube 3180 such that the distal end region3620 b of the pusher tube 3620 can be offset proximally from the distalend region 3610 b of the expandable carrier tube 3180. As desired, thepredetermined length 3628 a of the pusher tube 3620 can be greater thanor substantially equal to the predetermined length 3618 a of theexpandable carrier tube 3180. The pusher tube 3620 can be positioned inthe tube set 3605 with respect to the expandable carrier tube 3180 suchthat the expandable carrier tube 3180 and the pusher tube 3620 at leastpartially define a space 3660 distal to the distal end region 3620 b ofthe pusher tube 3620 and along the periphery 3612 of the expandablecarrier tube 3180. The space 3660 can be configured for housing orcontaining the offset-tubular clip 3500.

The pusher tube 3620 can be formed from a substantially rigid,semi-rigid, or flexible material. Also, the pusher tube 3620 can besubstantially tubular and can define a lumen 3624 that extendssubstantially between the proximal end region 3620 a and the distal endregion 3620 b and that is configured to slidably receive at least aportion of the expandable carrier tube 3180 so that the inner diameter3628 c of the pusher tube 3620 is equal to or larger than the outerdiameter 3618 b of the expandable carrier tube 3180. The outer diameter3628 b of the pusher tube 3620 can be substantially uniform, althoughnon-uniform diameters are also possible.

Also, the distal end region 3620 b of the pusher tube 3620 can includeone or more longitudinal extensions 3625, which extend distally from thepusher tube 3620 and along the periphery 3612 of the expandable carriertube 3180. The longitudinal extensions 3625 can be configured to pushthe clip during deployment. As such, the longitudinal extensions caninclude at least a first extension 3625 a, a second extension 3625 b,and a third extension 3625 c, where the first extension 3625 a is moredistally disposed compared to the second extension 3625 b that is moredistally disposed compared to the third extension 3625 c. Accordingly,the extensions 3625 a-c can be offset so as to facilitate deployment ofan offset-tubular clip 3500. Alternatively, the extensions 3625 a-c canbe blunt as described in connection with other embodiments. Thelongitudinal extensions 3625 a-c can be biased such that thelongitudinal extensions 3625 a-c extend generally in parallel with acommon longitudinal axis 3650. The longitudinal extensions 3625 a-c canbe sufficiently flexible to expand radially or bend outwardly, and yetsufficiently rigid to inhibit buckling, as the distal end region 3620 bis directed distally along the expandable carrier tube 3180 and engagesthe offset-tubular clip 3500 for deployment.

Additionally, the pusher tube 3620 can include a portion of a body 3621that is configured to radially expand or bend outwardly either bystretching or by including splittable slits 3623 in the portion that canseparate along the lumen 3624. The splittable slits 3623 a-b can bespaced apart so as to form pushing flap ends 3626 after being split.Additionally, the splittable slits 3623 can extend at least partiallydown the length 3628 a of the pusher tube 3620, and can be continuous,intermittent, or can include perforations. The splittable slits 3623 canalso extend radially from the lumen 3624 to the outer periphery 3622.For example, when the expandable carrier tube 3180 expands so as tointeract with the pusher tube 3620, the splittable slits 3623 a and 3623b can split and separate so as to form the pusher flaps 3626. The pusherflaps 3626 can then retain the pushing capability so as to push theoffset-tubular clip 3500 for delivery.

As shown in FIGS. 41A and 41E, a cover tube 3630 can be configured toretain the offset-tubular clip 3500 substantially within the carrierassembly 3002 prior to deployment. Being coupled with, and slidablerelative to, the pusher tube 3620, the cover tube 3630 can have aproximal end region 3630 a and a distal end region 3630 b. Also, thecover tube 3630 can include a predetermined length 3638 a, apredetermined outer diameter 3638 b, and a predetermined inner diameter3638 c, any of which can be of any suitable dimension. Additionally, thecover tube 3630 can have an outer periphery 3632 and have a body 3631that defines a lumen 3634. The cover tube 3630 can be configuredsubstantially similarly as described in connection with FIG. 38E.

Additionally, the distal end region 3630 b of the cover tube 3630 caninclude one or more longitudinal extensions 3635, which extend distallyfrom the cover tube 3630 and along an outer periphery 3622 of the pushertube 3620. Although the longitudinal extensions 3635 can extendgenerally in parallel with a common longitudinal axis 3650, thelongitudinal extensions 3635 can be biased such that the plurality oflongitudinal extensions 3635 extend substantially radially inwardly.Thereby, the longitudinal extensions 3635 can at least partially closethe lumen 3634 substantially adjacent to the distal end region 3630 b ofthe cover tube 3630. To permit the offset-tubular clip 3500 to bedeployed from the annular cavity 3670, the longitudinal extensions 3635can be sufficiently flexible to expand radially or bend outwardly so asto permit the distal end region 3610 b of the carrier tube 3610 to movedistally past the cover tube 3630 to open the annular cavity 3670 suchthat the distal end region 3630 b no longer extends over the space 3660.

As shown in FIGS. 41A and 41F, the tube set 3605 can include a supporttube 3640. The support tube 3640 can provide radial support for theother tubes within the tube set 3605. The carrier assembly 3002 canadvantageously include the support tube 3640, for example, to providesufficient support to the expandable carrier tube 3180 in the instanceit is not sufficiently rigid or under other circumstances in whichsupport for the expandable carrier tube 3180 or other tubes in the tubeset 3605 might be desirable.

The support tube 3640 can be formed as a substantially rigid,semi-rigid, or flexible tubular member. As such, the support tube 3640can include a proximal end region 3640 a and a distal end region 3640 b.The outer periphery 3642 of the support tube 3640 can define a lumen3644 that extends substantially between the proximal end region 3640 aand the distal end region 3640 b. The lumen 3644 can be configured toslidably receive and support at least a portion of a wire, a locatortube, or other type of movable member disposed therein. The support tube3640 can be at least partially slidably disposed within the lumen 3614of the expandable carrier tube 3180.

Additionally, the support tube 3640 can have a predetermined length 3648a, a predetermined outer diameter 3648 b, and a predetermined innerdiameter 3648 c, any of which can be of any suitable dimension. Also,the outer diameter 3648 b of the support tube 3640 can be substantiallyuniform and smaller than inner diameter 3618 c of the expandable carriertube 3180, and the inner diameter 3648 c of the support tube 3640 can belarger than the size of the wire, locator tube, or other type of memberthat can be disposed therein.

In another embodiment, the support tube 3640 can be configured similarlyas the expandable carrier tube 3180. As such, the support tube 3640 caninclude an expandable member 3100. In the instance the support tube 3640includes an expandable member 3100, the carrier tube 3610 may or may notbe configured as a expandable carrier tube 3180.

In the instance the carrier assembly 3002 is assembled as the pluralityof nested, telescoping members as shown in FIG. 41A, the support tube3640 can be at least partially disposed within, and slidable relativeto, the lumen 3614 of the expandable carrier tube 3180. Additionally,the expandable carrier tube 3180 can be at least partially disposedwithin, and slidable relative to, the lumen 3624 of the pusher tube3620. The pusher tube 3620, in turn, can be at least partially disposedwithin, and slidable relative to, the lumen 3634 of the cover tube 3630.In the instance a guidewire and/or locator tube to be disposed and/orslidable within the lumen 3644 of the support tube 3640 the longitudinalaxis thereof can be substantially in axial alignment with the commonlongitudinal axis 3650 of the expandable carrier tube 3180, the pushertube 3620, the cover tube 3630, and/or the support tube 3640. Althoughshown and described as being substantially separate for purposes ofillustration, it will be appreciated that the expandable carrier tube3180, the pusher tube 3620, the cover tube 3630, and/or the splittertube 2680 (FIGS. 22A-22E) can be provided, in whole or in part, as oneor more integrated assemblies.

Additionally, various methods of using a clip applier having anoffset-tubular clip to deliver the clip into tissue openings are shownin FIGS. 42A-43D. The methods can utilize embodiments of clip appliersas shown in the previous figures. As such, the use of a clip applierretaining a clip in an offset-tubular orientation and for delivering theclip can be used as shown, and can have many identical or similarstructures that perform identical or similar functions to theembodiments described above and in reference to the preceding figures.For example, the carrier tube carrying the offset-tubular clip can besubstantially similar to the foregoing carrier tubes and can be modifiedto have a shape that corresponds with the clip. Accordingly, thedescription below should be considered in view of the descriptions aboveof the preceding embodiments of clip appliers and clips and methods ofusing the same. Furthermore, those of ordinary skill in the art willappreciate that one or more of the uses, components, and/or features ofthe embodiment shown in FIGS. 42A-43D may also be incorporated in thepreviously described embodiments, and those components and/or featuresof the previously described embodiments may optionally be incorporatedin the various embodiments of clip appliers, clips, and methods of usedescribed below and in reference to FIGS. 42A-43D.

Referring now to FIGS. 42A-42E, methods of using a clip applier assembly3000 will be described. The clip applier assembly 3000 can besubstantially similar as depicted and described in connection with FIGS.38A-38F and/or 41A-41F, and may include various other features of clipappliers as described herein. The use of the clip applier 3000 isdepicted and described without the carrier tube 3310 or some othercomponent expanding the clip 3500; however, it should be recognized thata ramped or expandable carrier tube or some other expandable componentcan be used to expand the clip before being inserted into tissue asdescribed herein.

Referring now to FIG. 42A, there is shown a vessel 600 disposed below apatient's tissue 630 and skin 650, wherein a guidewire 3010 is disposedthrough an opening 610 formed in the vessel wall 620 and tissue 630 sothat the guidewire 3010 is located within the vessel 600. The guidewire3010 may be introduced into the blood vessel for the sole purpose ofguiding the positioning of the carrier assembly 3000 to deploy anoffset-tubular clip 3500. Alternatively, the guidewire 3010 may havealready been present from a previously completed interventionalprocedure.

As shown in FIG. 42B, a locator tube 3220 can be threaded over theguidewire 3010 by inserting the proximal end of the guidewire 3010 intothe central lumen of the locator tube 3220 at the distal end 3220 b ofthe locator tube 3220, the guidewire 3010 is disposed through the deviceand exits at the proximal end (not shown) of the locator tube 3220. Thelocator tube 3220 can be advanced along the guidewire 3010 until thedistal end 3220 b of the locator tube 3220 is disposed through theopening 610 formed in the blood vessel wall 620. The locator tube 3220can be oriented at an angle beta with respect to the blood vessel 620,and can be retained at about the angle beta throughout the clipdeployment procedure.

Previously, such techniques have been performed with the locator beingnormal to the blood vessel (e.g., 90 degrees or orthogonal) during theclip deployment procedure. However, a clip applier having anoffset-tubular clip can allow the locator to be inserted and retained atthe angle beta, which can be about 20 to 70 degrees, more likely fromabout 30 to 60 degrees, even more likely from about 40 to 50 degrees,and most likely about 45 degrees. Alternatively, the device can beorientated at an angle complementary to the angle at which the puncturewas made to access the vessel or lumen. Also, the angle beta cancorrespond with the angle the clip is offset in the carrier assembly.This can be beneficial for delivering the clip into the vessel becausethe tip of the tines can contact the tissue as substantially the sametime. Also, routine medical techniques usually involve introducinginstruments, which can include locator tubes and clip appliers, into ablood vessel at an introduction angle, such as 30 degrees. As such, theprevious techniques involved orienting the locator from the introductionangle to being normal with respect to the vessel, which can damage thevessel or cause unfavorable tissue compression at the superior side ofthe locator by displacement of the distal end of the locator.Accordingly, inserting and retaining the locator in the vessel at theangle beta throughout a clip application procedure can minimize theamount of potential damage to the tissue and tissue compression at thesuperior side.

With continuing reference to FIG. 42B, the flexible and extendablemembers 3230 on the distal end 3220 b of the locator tube 3220 can beexpanded so as to transition the locator tube 3220 from the unexpandedstate to the expanded state. The expandable portion may be expandedthrough removal of a sheath as described above, whereby the expandableportion would translate from an unexpanded configuration to an expandedconfiguration. Alternatively, the expandable portion may be activelyexpanded by proximal motion of the support tube, wherein the supporttube would include an enlarged diameter portion, initially disposeddistal the distal end of the expandable portion, proximal motion of theenlarged diameter portion would cause the expandable portion totranslate from an unexpanded position to an expanded position. In theexpanded state, the extendable members 3230 can engage the inside 620 bof the vessel wall 620 at the location of the opening 610 in the bloodvessel wall 620. The correct position of the device at this point may beconfirmed by gently pulling on the locator tube 3220 to feel theresistance of the vessel wall against the flexible members 3230 in theexpanded state. After verifying the correct position in this manner, theguidewire 3010 may be removed from the vessel 600 and from the locatortube 3220 by withdrawing the guidewire 3010 through the proximal end ofthe locator tube 3220.

Referring now to FIG. 42C, the tube set 3305 including an expandablecarrier tube 3310 can be positioned adjacent to the outer wall 620 a ofthe blood vessel 600 as described herein. Briefly, the tube set 3305 canbe moved distally down the locator tube 3220 toward the vessel 600. Uponreaching the first predetermined position, the tube set 3305 can bedisposed substantially adjacent to the outer surface 620 a of the bloodvessel wall 620 adjacent to the opening 610. The cover member 3330 andthe support tube 3340 can each decouple from the carrier tube 3310 andthe pusher tube 3320. Thereby, the cover tube 3330 and support tube 3340can be inhibited from further axial movement and remain substantiallystationary as the carrier tube 3310 and the pusher tube 3320 each remaincoupled and axially slidable.

Accordingly, the cover tube 3330 and the support tube 3340 can remainsubstantially stationary while the carrier tube 3310 and the pusher tube3320 can continue distally and approach a second predetermined position.As the carrier tube 3310 and the pusher tube 3320 distally advancetoward the second predetermined position, the distal end region 3330 bof the cover tube 3330 no longer encloses the carrier tube 3310 and thepusher tube 3320. Thereby, the offset-tubular clip 3500 may not becompletely enclosed by the cover tube 3330.

Although not completely enclosed, the offset-tubular clip 3500 can beadvantageously retained on the outer periphery 3312 of the carrier tube3310. For example, by retaining the offset-tubular clip 3500 on thecarrier tube 3310, the clip 3500 can be positioned closer to the vesseltissue 620 a surrounding the opening 610.

When the tube set 3305 is in the second predetermined position, thecarrier tube 3310 can decouple from the pusher tube 3320 in the mannerdescribed in more detail above. The carrier tube 3310, the cover tube3330, and the support tube 3340 can be inhibited from further axialmovement and remain substantially stationary; whereas, the pusher tube3320 remains axially slidable. As the pusher tube 3320 continuesdistally, the distal end region 3320 b of the pusher tube 3320 cancontact and push the offset-tubular clip 3500 to the distal end 3310 bof the carrier tube 3310. As such, the pusher tube 3320 can displace theclip 3500 from the carrier tube 3310 so that it contacts the tissue 620a around the opening 610 in the vessel (as shown).

While not shown, the carrier tube 3310 can have a distally-increasingcross-section. As such, the pusher tube 3320 can direct theoffset-tubular clip 3500 over the distally-increasing cross-section ofthe distal end region 3310 b of the substantially-stationary carriertube 3310 such that the lumen of the clip 3500 radially expands.

Upon being directed over the distal end region 3310 b of the carriertube 3310 by the pusher tube 3320, the offset-tubular clip 3500 can bedistally deployed. When the clip 3500 is deployed, the tines 3520 canpierce and otherwise engage a significant amount of the blood vesselwall 620 a and/or tissue 630 adjacent to the opening 610. Accordingly,the clip 3500 can be released from the carrier tube 3310 by being pushedby the pusher tube 3320.

Referring now to FIG. 42D, the clip 3500 is shown to be deployed fromthe carrier tube 3310. At some point in the deployment process, the clip3500 can retract from an offset-tubular orientation (e.g., retainingconfiguration) to a tubular orientation that is substantially even orsymmetrical about the central axis of the clip (e.g., deployingconfiguration). As such, the clip 3500 can retract from being offset tosymmetrical so that opposing tines 3520 a-b are substantially even orparallel, which is shown by the dashed lines. The clip 3500 can retractfrom the retaining configuration to the deploying configuration at anytime during the deployment process, which can include while beingdeployed from the carrier tube 3310 through after being released fromthe carrier tube 3310. In any event, the clip 3500 can retract from theretaining configuration to the deploying configuration before closingthe opening.

Turning to FIG. 42E, as the clip 3500 is being deployed into the tissue620 a of the vessel 620, the extendable members 3230 can collapse andthe locator tube 3220 can be pulled through the opening 610 and out ofthe vessel 600. As this occurs, the tissue held by the tines 3520 can bepulled inwardly to close the opening 610. In this instance, thecross-section of the clip 3500 is expanded during deployment, more bloodvessel wall 620 a and/or tissue 630 can be drawn into the channel 3540of the clip 3500 and engaged by the tines 3520. Also, the clip 3500 canexpand when retracting from the retaining configuration to the deployingconfiguration so that the distance between opposing tines 3520 a-bincreases during delivery. In any event, the tines 3520 can engageenough of the blood vessel wall 620 and/or tissue 630 to adequatelyclose the opening independent of whether or not the clip 3500 isexpanded during delivery.

Accordingly, the clip 3500, once deployed, transitions from theoffset-tubular orientation (e.g., retaining configuration; FIGS.35A-35B) to the symmetrical orientation (e.g., deploying configuration;FIGS. 34A-34B) before returning to the natural, planar orientation(e.g., relaxed configuration; FIGS. 33A-33B) with opposing tines 3520a-b pointing inwardly. In another embodiment, the clip 3500substantially uniformly transitions from the retaining configurationthrough the deploying configuration to the relaxed configuration. Whilerotating axially inwardly, the tines 3520 draw the blood vessel wall 620and/or tissue 630 into the channel 3540. Thereby, the opening 610 in theblood vessel wall 620 can be drawn substantially closed and/or sealedvia the clip 3500 as illustrated. Also, after the clip 3500 has beendeployed into the vessel 600, the locator tube 3220 and clip applier3000 can be retracted.

Referring now to FIGS. 43A-43D, methods of using a clip applier assembly3002 in accordance with the present invention will be described. Theclip applier assembly 3002 can be substantially similar as depicted anddescribed in connection with FIGS. 41A-41F, and may include variousother feathers of clip appliers as described herein. The use of the clipapplier 3002 is depicted and described with an expandable carrier tube3180; however, it should be recognized that another expandable elementcan be used in place of the expandable carrier tube 3180 to expand theclip 3500 before being inserted into tissue as described herein.

As shown in FIGS. 43C-43D, a guidewire 3010 can be inserted through anopening 610 in a vessel wall 620 so that a locator tube can be disposedtherein at an angle beta with respect to the vessel 600. Accordingly,the clip applier 3002 can be placed adjacent to the vessel wall 620 atthe opening 610 by being guided over the locator tube as describedherein. Advantageously, the clip applier 3002 can be retained at theangle beta with respect to the vessel 600 during deployment of the clip3500.

Referring now to FIG. 43A, the tube set 3605 including an expandablecarrier tube 3180 can be positioned adjacent to the outer wall 620 a ofthe blood vessel 620 as described herein. Briefly, the tube set 3605 canbe moved distally down the locator tube 3220 toward the vessel all 620.Upon reaching the first predetermined position, the tube set 3605 can bedisposed substantially adjacent to the outer surface 620 a of the bloodvessel wall 620 adjacent to the opening 610. The cover member 3630 andthe support tube 3640 can each decouple from the expandable carrier tube3180 and the pusher tube 3620. Thereby, the cover tube 3630 and supporttube 3640 can be inhibited from further axial movement and remainsubstantially stationary as the expandable carrier tube 3180 and thepusher tube 3620 each remain coupled and axially slidable.

Accordingly, the cover tube 3630 and the support tube 3640 can remainsubstantially stationary while the expandable carrier tube 3180 and thepusher tube 3620 can continue distally and approach a secondpredetermined position. As the expandable carrier tube 3180 and thepusher tube 3620 distally advance toward the second predeterminedposition, the distal end region 3630 b of the cover tube 3630 no longerencloses the expandable member 3100 a of the expandable carrier tube3180. Thereby, the offset-tubular clip 3500 may not be completelyenclosed by the cover tube 3630. Although not completely enclosed, theoffset-tubular clip 3500 can be advantageously retained on the outerperiphery 3612 of the expandable carrier tube 3180 or on the expandablemember 3100 a. For example, by retaining the offset-tubular clip 3500 onthe expandable carrier tube 3180 or the expandable member 3100 a, theclip 3500 can be positioned closer to the vessel tissue 620 asurrounding the opening 610.

When the tube set 3605 is in the second predetermined position, theexpandable carrier tube 3180 can decouple from the pusher tube 3620 inthe manner described in more detail above. The expandable carrier tube3180, the cover tube 3630, and the support tube 3640 can be inhibitedfrom further axial movement and remain substantially stationary;whereas, the pusher tube 3620 can remain axially slidable. As the pushertube 3620 continues distally, the distal end region 3620 b of the pushertube 3620 can contact and push the offset-tubular clip 3500 to theexpandable member 3100 a of the expandable carrier tube 3180.

Referring now to FIG. 43B, after the tube set is in the secondpredetermined position the expandable member 3100 can be expanded from acollapsed orientation (3100 a) to an expanded orientation (3100 b). Assuch, the distal portion 3104 can be significantly expanded so that theexpandable member 3100 b has a distally-increasing orthogonalcross-sectional profile. Also, the proximal portion 3102 of theexpandable member 3100 b can be substantially not expanded or onlyminimally expanded so that the expandable member 3100 b can expand theclip 3500 when being pushed over the expanded expandable member 3100 b.Accordingly, the expandable member 3100 b can be expanded as describedin connection with FIGS. 39A-40C. Accordingly, the expandable member3100 b can be selectively expanded so that the entire length is expandedor selectively expanded so as to form a substantially conical shape asshown. The expandable member 3100 b can be expanded similarly toexpanding a stent, which is well known in the art. In part, theexpandable member 3100 b can be expanded at any time, which includeswhile being disposed within the cover tube 3630 or after being pusheddistally past the cover tube 3630. In some instances, the expandablemember 3100 b can be expanded by merely being slid distally past thecover tube 3630. In other instances, the expandable member 3100 b can beexpanded by actuating a mechanism (not shown) that selectively expandsthe expandable member 3100 b. In any event, expansion of the expandablemember 3100 b can allow the pusher tube 3620 to direct theoffset-tubular clip 3500 over the distally-increasing cross-section thesubstantially-stationary expandable carrier tube 3180 or expandablemember 3100 b such that the lumen of the clip 3500 radially expands.

Referring now to FIG. 43C, the offset-tubular clip 3500 can be pushedover the expandable member 3100 b by the pusher tube 3620 being pusheddistally toward the blood vessel wall 620. Upon being directed over theexpandable member 3100 b of the expandable carrier tube 3180 by thepusher tube 3620, the offset-tubular clip 3500 can be distally deployed.As shown, the first tine 3520 a can be pushed over the expandable member3100 b before the second tine 3520 b. Alternatively, the offset-tubularclip 3500 can be pushed over the expandable member 3100 b in a mannerthat allows the first tine 3520 a to become substantially even orsymmetrical with the second tine 3520 b so as to retract from theretaining configuration to the deploying configuration. In any event,the clip 3500 can radially expand while being pushed over the expandablemember 3100 b by the pusher tube 3620.

Referring now to FIG. 43D, when the expanded clip 3500 is deployed fromthe expandable member 3100 b, the tines 3520 can pierce and otherwiseengage a significant amount of the blood vessel wall 620 a and/or tissue630 adjacent to the opening 610. Accordingly, the clip 3500 can bereleased from the expandable member 3100 b by being pushed by the pushertube 3320. As such, the pusher tube 3320 can displace the clip 3500 fromthe expandable carrier tube 3180 so that it contacts the tissue 620 aaround the opening 610 in the vessel (as shown).

At some point in the deployment process, the clip 3500 can retract froman offset-tubular orientation (e.g., retaining configuration) to atubular orientation that is substantially even or symmetrical about thecentral axis of the clip (e.g., deploying configuration). As such, theclip 3500 can retract from being offset to being symmetrical so thatopposing tines 3520 a-b are substantially even or parallel, which isshown by the first tine 3520 a and the second tine 3520 b penetratingthe tissue at approximately the same time. The clip 3500 can retractfrom the retaining configuration to the deploying configuration at anytime during the deployment process, which can include while beingdeployed over the expandable member 3100 b of the expandable carriertube 3180 (not shown) through after being released from the expandablemember 3100 b as shown. In any event, the clip 3500 can retract from theretaining configuration to the deploying configuration before closingthe opening.

Referring back to FIG. 42E, as the clip 3500 is being deployed into thetissue 620 a of the vessel 600, the locator tube 3220 can be pulledthrough the opening 610 and out of the vessel 600. As this occurs, thetissue held by the tines 3520 can be pulled inwardly to close theopening 610. Additionally, the expanded cross-section of the clip 3500can allow for more blood vessel wall 620 a and/or tissue 630 can bedrawn into the channel 3540 of the clip 3500 and engaged by the tines3520. Also, the clip 3500 can expand when retracting from the retainingconfiguration to the deploying configuration so that the distancebetween opposing tines 3520 a-b increases during delivery. In any event,the tines 3520 can engage enough of the blood vessel wall 620 a and/ortissue 630 to adequately close the opening independent of whether or notthe clip 3500 is expanded during delivery.

Accordingly, the offset-tubular clip 3500, once deployed, transitionsfrom the offset-tubular orientation (e.g., retaining configuration;FIGS. 35A-35B) to the symmetrical orientation (e.g., deployingconfiguration; FIGS. 34A-34B) before returning to the natural, planarorientation (e.g., relaxed configuration; FIGS. 33A-33B) with opposingtines 3520 a-b pointing inwardly. In another embodiment, theoffset-tubular clip 3500 substantially uniformly transitions from theretaining configuration through the deploying configuration to therelaxed configuration. While rotating axially inwardly, the tines 3520draw the blood vessel wall 620 a and/or tissue 630 into the channel3540. Thereby, the opening 610 in the blood vessel wall 620 can be drawnsubstantially closed and/or sealed via the clip 3500 as illustrated.

While not shown, the expandable member 3100 can be collapsed from theexpanded orientation (3100 b; FIG. 40B) to the collapsed orientation(3100 a; FIG. 40A). However, the expandable member 3100 need not becollapsed after deployment of the clip. In any event, after the clip3500 has been deployed into the vessel wall 620, the locator tube 3220and clip applier 3000 can be retracted independent of whether or not theexpandable member 3100 is collapsed.

The apparatus is configured to receive and retain the closure elementsuch that the closure element is disposed substantially within theapparatus. Thereby, if the apparatus is introduced via an introducersheath, for example, the closure element can be disposed within, anddelivered by way of, a lumen of the introducer sheath. The apparatusalso is configured to engage the blood vessel wall adjacent to theopening and to position the closure element substantially adjacent to anouter surface of the blood vessel wall adjacent to the opening.

When properly positioned, the apparatus can be activated to distallydeploy the closure element. During deployment, the apparatus preferablyis configured to substantially uniformly expand the closure elementbeyond a natural cross-section of the closure element such that theclosure element, when deployed, is configured to engage a significantamount of the blood vessel wall and/or tissue. Engaging the blood vesselwall and/or tissue, the closure element is further configured to returnto the natural cross-section. Thereby, the engaged blood vessel walland/or tissue are drawn substantially closed and/or sealed, such that,for example, hemostasis within the opening is enhanced.

In one specific embodiment, an apparatus is provided for delivering anddeploying a substantially resilient closure element through tissue to anopening in a body lumen perimeterically defined by opposing arterialwalls. The closure element is configured to substantially uniformlydeform from a natural, substantially resilient planar configuration to asubstantially tubular configuration, having a substantially naturaltransverse cross-sectional dimension. The apparatus includes a deliveryassembly positionable through the tissue and into the opening in thebody lumen, and having a distal tissue engaging device and a carrierassembly. The carrier assembly is configured to carry and support theclosure element in the substantially tubular configuration in a firstdiameter. The distal tissue engaging device is selectably axiallydisplaceable relative to at least a portion of the carrier assemblybetween a tissue engaging condition and a tissue closing condition. Inthe tissue engaging condition, the opposing arterial walls of the bodylumen are engaged adjacent to the opening. In contrast, in the tissueclosing condition, the engaged opposing arterial walls are urgedsubstantially transversely together such that the closure element may bedeployed from the delivery assembly, while substantially maintained inthe first diameter, into the opposing arterial walls. The closureelement is oriented to engage the engaged opposing arterial walls whendeployed and to return to the natural, substantially planarconfiguration and the natural, transverse cross-sectional dimension suchthat the engaged opposing arterial walls are drawn substantially closed.

The distal tissue engaging device includes two or more opposed engagingtongs having respective end tips configured to open radially indirections extending beyond the first diameter of the carrier assemblyto initially engage the opposing arterial walls, in the engagingcondition. These engaging tongs are configured to close radially inwardsuch that the engaged opposing arterial walls are disposed within thefirst diameter of the closure element, in the substantially tubularconfiguration, in the closing condition.

In another specific embodiment, the carrier assembly includes a covermember protecting the delivery assembly such that at least the closureelement is contained therein. The cover member defines a lumenconfigured for slidable receipt of the closure element therein. Thedistal tissue engaging device is integral with a distal end of the covermember to enable movement of the two or more opposing tongs between theengaging condition and the closing condition.

Still another specific arrangement provides a delivery assembly that isformed and dimensioned for sliding axial, reciprocating, receipt in alumen of an introducer sheath extending through the tissue andterminating proximate the opening. The tissue engaging device isconfigured to cooperate with the introducer sheath to enable movementbetween the engaging condition and the closing condition. Further, thetwo or more tongs are formed and dimensioned for sliding contact withthe sheath lumen to effect movement between the engaging condition andthe closing condition.

In yet another specific embodiment, the carrier assembly includes acarrier seat configured to seat the closure element, in thesubstantially tubular configuration, on the delivery assembly prior todeployment. The delivery assembly includes a tubular body supporting thecarrier seat, and defines a central receiving lumen extendinglongitudinally therethrough that is configured for sliding support ofthe tissue engaging device for axial movement between the engagingcondition and the closing condition. Each of the two or more tongs arebowed and biased radially outward, relative one another, from alongitudinal axis of the tubular body such that an end tip of eachrespective tong is urged outward and toward gripping intravascularengagement with an undersurface of the opposing arterial walls, in theengaging condition, when the tissue engaging device extends distallyfrom the central lumen of the tubular body.

In another aspect of the present invention, a closure system is providedfor closing an opening formed in a body lumen perimeterically defined byopposing arterial walls. The system includes a closure element adaptedto deform from a natural, substantially resilient planar configurationto a substantially tubular configuration, having a substantially naturaltransverse cross-sectional dimension. A delivery assembly ispositionable through the tissue and into the opening in the body lumen.The delivery assembly includes an elongated body, a carrier assembly anda distal tissue engaging device. The carrier assembly includes a carrierseat configured to carry and peripherally support the closure element inthe substantially tubular configuration, in a first diameter. The distaltissue engaging device is selectably axially displaceable relative tothe carrier seat between the engaging condition and the closingcondition, while substantially maintaining the engaged walls within thefirst diameter. A pusher member is slidably disposed about the elongatedbody for relative axial sliding displacement therebetween. The pushermember includes a contact portion disposed proximally adjacent theclosure element. The pusher member is applied to selectively distallydeploy the closure element from the carrier assembly, in thesubstantially tubular configuration, to engage the opposing arterialwalls and to return to the natural, substantially planar configurationand the natural, transverse cross-sectional dimension such that theengaged opposing arterial walls are drawn substantially closed.

In yet another aspect of the present invention, a method for closing anopening perimeterically defined by edges of the arterial walls of a bodylumen is provided including placing a distal end region of a locatorportion through tissue into the opening; and engaging the arterial wallsadjacent to the opening. The method further includes positioning adistal end region of a carrier assembly through the tissue adjacent tothe opening. The carrier assembly is oriented proximal to the locatorportion, and the distal end region of the carrier assembly includes acarrier seat configured to seat the closure element thereon in asubstantially tubular configuration, having a first diameter. The methodincludes urging the engaged arterial walls radially inward and towardone another such that at least opposed edges of the arterial walls aredrawn with the first diameter of the closure element. The closureelement is distally deployed from the carrier assembly without furthersubstantial radial expansion for the closure element, in thesubstantially tubular configuration, such that the closure elementengages the arterial walls, and returns to the natural, planarconfiguration and the natural cross-section wherein the tissue is drawnsubstantially closed.

In one specific embodiment, the engaging of the arterial walls isperformed by extravascularly engaging the arterial walls with a tissueengaging device. In contrast, the engaging of the arterial walls isperformed by intravascularly engaging the arterial walls with a tissueengaging device.

Referring now generally to FIGS. 44-47 and 51A-51H, a clip or closureapplier apparatus, generally designated 4100, is provided for deliveringand deploying a closure element 4500 to an opening 4610 formed in a bodylumen, such as a blood vessel 4600; the opening 4610 of which isperimeterically defined by opposing tissue arterial walls 4620′, 4620″(FIG. 51A). Briefly, as shown in FIGS. 46A-46G, the closure element 4500itself is configured to resiliently deform between a natural,substantially planar configuration (after a curing process (FIG. 46C))to a substantially tubular configuration (FIGS. 46F and 46G). Further,the closure element can also be resiliently deformed and radiallydisplaced up to an expanded substantially tubular configuration, havinga greater cross-sectional dimension, from its natural substantiallytubular configuration (FIGS. 51F and 51G), or can be displaced down to areduced substantially tubular configuration, having a lessercross-sectional dimension.

Returning to the clip applier apparatus 4100, in accordance with thepresent invention, a delivery assembly, generally designated 4200, isincluded that is positionable through the tissue 4630 and into theopening 4610. The delivery assembly 4200 includes a distal tissueengaging device 4400 and a carrier assembly 4300, oriented just proximalto the distal tissue engaging device, that houses and supports theclosure element 4500″. The carrier assembly 4300 includes a carrier seatportion 4302 configured to carry and support the closure element 4500″in a slightly expanded substantially tubular configuration (FIG.50A-50C), in a first diameter, that is slightly greater than that in anatural, substantially tubular condition.

The distal tissue engaging device 4400 is selectably axiallydisplaceable relative to the carrier assembly 4300 between a tissueengaging condition (FIG. 51D) and a tissue closing condition (FIG. 51F).In the tissue engaging condition, the tissue engaging device 4400engages the opposing arterial walls 4620′, 4620″ (e.g., FIGS. 51D-51E)of the body vessel 4600 adjacent to the opening 4610 so that the engagedwalls can be pulled or urged radially inward or transversely toward oneanother in the closing condition (FIGS. 51F-51G). Hence, in the closingcondition, the engaging device 4400 urges the opposing arterial walls4620′, 4620″ at the opening 4610, substantially closer together andtoward one another radially. By closing the opposing arterial wallswithin the first diameter of the closure element 4500″ (mounted aboutthe carrier seat 4302 in the substantially tubular configuration), theclosure element can be deployed directly there from without having tofurther radially expand the same to sufficiently engage the tissue.

Hence, applying a pusher member 4320 (as will be described), the closureelement 4500″, which is retained in the substantially tubularconfiguration, can be deployed into the opposing arterial walls (FIG.51G). Subsequently, once the closure element engages the opposingarterial walls 4620′, 4620″ and is released from the delivery assembly,it returns to the natural, substantially planar configuration and thenatural cross-section dimension such that the engaged opposing arterialwalls are drawn substantially closed (FIG. 51H).

In accordance with the present invention, since the closure element4500″ can be deployed from the closure applier apparatus 4100 withoutrequiring substantial further radial expansion from the substantiallytubular configuration atop the carrier assembly, the overall complexityof the closure applier can be significantly reduced. In turn, thediametric footprint can be significantly reduced, as compared toprevious designs, which in effect permit the use of a smaller diameterGF introducer sheath. Moreover, a closure applier apparatus is providedthat fully encloses the closure element within itself during advancementto the tissue site, prior to deployment and delivery to the targetedvessel walls. Unlike many current designs, the present inventionsignificantly reduces potential tissue snag or contact by the closureelement during advancement and positioning. This enclosure approach issimilar to those disclosed in co-pending U.S. patent application Ser.No. 11/455,993, filed Jun. 19, 2006, and entitled “APPARATUS AND METHODFOR DELIVERING A CLOSURE ELEMENT”; and U.S. patent application Ser. No.10/356,214, filed Jan. 30, 2003, entitled “CLIP APPLIER AND METHODS OFUSE” (hereinafter referred to as the '214 patent application), each ofwhich is herein incorporated by reference in their entirely. Thesedesigns prove much more desirable and provide a basis for a wide rangeof medical applications, such as diagnostic and/or therapeuticprocedures involving blood vessels or other body lumens of any size.

As will be discussed in more detail below, the clip applier apparatus4100 can deliver a closure element 4500″ (shown in FIGS. 46F-G) throughtissue 4630 (shown in FIG. 51A) and into an opening 4610 formed inand/or adjacent to and perimeterically defined parametrically by thearterial walls 4620 (e.g., the opposed arterial walls 4620′, 4620″) of ablood vessel 4600 or other body lumen. The closure element (or clip)4500 preferably has a generally annular-shaped body 4510 (shown in FIGS.46A-46B) defining a channel 4540 and one or more barbs and/or tines 4520for receiving and engaging the blood vessel wall 4620 and/or the tissue4630 around the opening 4610. Although the closure element 4500, whenoriginally fabricated, has a natural shape and size, the closure element4500 can be deformed into other shapes and sizes, as desired, and isconfigured to return to the natural shape and size when released. Forexample, the closure element 4500 can have a natural, planarconfiguration with opposing tines 4520 and a natural cross-section 4530as shown in FIGS. 46A-46B. Via a heat-treating process, disclosed inU.S. Pat. No. 6,623,510 to Carley et al., incorporated herein byreference in its entirety, the natural cross-section 4530 of the closureelement 4500 will be reduced to form a reduced closure element 4500′that has a natural, planar configuration with opposing tines 4520 and areduced cross-section 4530′ as shown in FIGS. 46C-46D. By rotating theopposing tines 4520 axially as shown in FIG. 46E, the cured closureelement 4500′ can be further deformed to form a substantially tubularclosure element 4500″ (shown in FIG. 46F) having a generallyannular-shaped body 4510′ with an outer diameter 4530′ and an innerdiameter 4550. In this substantially tubular configuration with thetines 4520 in an axial configuration (FIG. 46G which is theconfiguration when loaded on the carrier assembly configuration, albeitslightly expanded), the resulting cross-section 4530′ when loaded isexpanded as well.

Being configured to draw the opposed blood vessel arterial walls 4620′,4620″ and/or the tissue 4630 adjacent to the opening 4610 substantiallyclosed and/or to enhance hemostasis within the opening 4610, the closureelement 4500 can be formed from any suitable material, including anybiodegradable material, any shape memory alloy, such as alloys ofnickel-titanium, or any combination thereof. As desired, the closureelement 4500 can include radiopaque markers (not shown) or can be whollyor partially formed from a radiopaque material to facilitate observationof the closure element 4500 using fluoroscopy or other imaging systems.Exemplary embodiments of a closure element are disclosed in U.S. Pat.No. 6,197,042, in co-pending application Ser. Nos. 09/546,998;09/610,238 and 10/081,726. The disclosures of these references and anyothers cited therein are expressly incorporated herein by reference.

With the exception of the last specific embodiment shown in FIG. 58, theclip applier apparatus 4100 is configured to receive, retain andsubstantially enclose the closure element 4500″ within the apparatus4100. In the embodiments of FIGS. 44-45 and 47-58, as will be describedin greater detail below, the delivery assembly 4200 includes anelongated tubular body 4210 that supports a distal tissue locatorportion 4202 and the carrier seat 4302 of the carrier assembly 4300 thatis disposed proximal to the locator portion. The carrier assembly 4300further includes a cylindrical cover member or garage tube 4330enclosing the pusher member 4320, the tubular body 4210 and the carrierseat 4302 in a nested manner within its receiving lumen 4334 until theclosure element is prepared for deployment.

In each embodiment, if the apparatus 4100 is introduced via anintroducer sheath 4640 (shown in FIG. 51A), for example, the closureelement 4500″ can be disposed entirely within the garage tube 4330, anddelivered by way of the lumen 4644 (shown in FIG. 51A) of the introducersheath 4640. Being disposed substantially within the garage tube 4330 ofthe clip applier apparatus 4100 just prior to deployment of the closureelement 4500″, the delivery assembly 4200 can deeply penetrate thetissue 4630 adjacent to the opening 4610 without inadvertentlycontacting or snaring it. The delivery assembly 4200 can thus positionthe closure element 4500″ substantially adjacent to an outer surface4620 a (shown in FIG. 51A) of the blood vessel wall 4620 adjacent to theopening 4610.

Referring to the specific embodiments of FIGS. 44-45 and 47-58, eachclip applier apparatus 4100 includes a central distal tissue locatorportion 4202 and a carrier assembly 4300 supported on the end of, andintegrated with, the tubular body 4210 of the delivery assembly 4200.Briefly, the distal locator portion 4202 is configured to facilitatelocation of the opening 4610 into the blood vessel 4600, relative to thecarrier assembly 4300 and the tissue engaging device 4400 (e.g., FIGS.51D and 51E).

The carrier assembly 4300, on the other hand, is configured to carry andsupport the closure element 4500″ in the substantially tubularconfiguration (FIGS. 46F and 46G), albeit in a slightly expandedconfiguration from its natural tubular configuration. In this manner,the resiliency of the closure element 4500″ itself, together with theconfinement of the cover member 4330, function to secure it to thecarrier seat 4302 of the carrier assembly 4300. When deployed, theclosure element 4500″ (in the substantially tubular configuration) isoriented with its tines directed distally to engage the blood vesselwall 4620 and/or the tissue 4630 around the opening 4610, and to returnto the natural, substantially planar configuration and the naturalcross-section such that the engaged tissue is drawn substantially closed(FIG. 51H).

Once strategically oriented, the clip applier apparatus 4100 can beactivated to distally deploy the closure element 4500″. It will beappreciated that although the closure element 4500″ is capable ofsignificantly greater radial expansion from its tubular configurationmounted to the carrier assembly 4300 of the tubular body 4210, thedelivery assembly is designed to deploy the closure element 4500″directly from the carrier seat 4302 without requiring any furthersignificant radial expansion.

The apparatus 4100 can be provided as one or more integrated componentsand/or discrete components. As shown in the embodiment of FIGS. 44-45and 47-51, for example, the apparatus 4100 can include an elongateddelivery assembly 4200 having an integral tissue engaging device 4400,central vessel locator (or obturator) portion 4202 and carrier assembly4300, that carries the closure element 4500″ thereon, on a singlesubsystem. In contrast, in the embodiments of FIGS. 52-58, the tissueengaging device 4400 is contained on a separate subsystem from thecarrier assembly 4300 and the vessel locator portion 4202, all of whichcooperate with one another to deploy the closure element.

In fact, in accordance with the present invention, it is the position,implementation and execution of the tissue engaging device 4400 thatdifferentiates each embodiment. In one specific embodiment, for example,the tissue engaging device 4400 is disposed on the distal end to thecover member 4330 (FIGS. 44-45, and 47-51), where it is selectivelyoperated between the tissue engaging condition (FIGS. 51D, 51E) and theclosing condition (FIGS. 51F, 51G). In contrast, in the embodiments ofFIGS. 52-58, the tissue engaging device 4400 is disposed within acentral lumen 4204 of the tissue locator portion 4202, and isselectively operated as it is distally advanced from the lumen. It willbe appreciated that these differing implementations of the tissueengaging devices will each be detailed separately below.

In each implementations, however, the tissue engaging device 4400 iscapable of gripping, snaring and/or piercing the tissue arterial walls4620, and urging them together and radially inward, toward one another,such that portions of the arterial walls 4620′, 4620″ are axiallycontained within the first diameter of the closure element 4500″, in thesubstantially tubular configuration. As mentioned, this arrangementenables the deployment of the closure element 4500″ directly from thecarrier seat 4302 of the carrier assembly 4300 without requiring furtherradial expansion.

Referring back to FIGS. 47-51, the first specific embodiment will bedescribed in detail. In this particular arrangement, the distal tissuelocator portion 4202 (obturator) is configured to extend into theopening 4610 and selectably engage an inner surface 4620 b of the bloodvessel wall 4620 (FIG. 51D). Thereby, the distal locator portion 4202 isconfigured to draw the blood vessel wall 4620 taut, and maintain theproper position of the clip applier apparatus 4100 as the blood vessel4600 pulsates. Briefly, in cooperation with the tissue engaging device4400 oriented at the distal end of the cover member 4330, once thedistal locator portion 4202 is properly aligned and positioned, thetissue engaging device can be operated to engage the arterial walls,drawing them radially together as will be described below.

First, the delivery assembly 4200 of this embodiment will be detailedwhich includes the tubular body 4210, the carrier assembly 4300 and thedistal locator portion 4202 integrated on a single subsystem. Thetubular body 4210 is preferably provided by a flexible, semi-rigid orrigid, tubular structure, such as an elongate rail, with a longitudinalaxis 4216. As illustrated in FIGS. 45 and 47A, the tubular body 4210 hasa proximal end region 4210 a and a distal end region 4210 b thatsupports the carrier seat 4302 of the carrier assembly 4300 justproximal to the distal locator portion 4202.

The tubular body 4210 is preferably of a predetermined length 4218 a anda predetermined outer cross-section 4218 b (FIG. 45), both of which canbe of any suitable dimension. The distal section of the distal locatorportion 4202 preferably includes a substantially rounded, soft, and/orflexible distal end or tip 4220 to facilitate atraumatic advancementand/or retraction of the distal section into the blood vessel 4600. Asdesired, a pigtail (not shown) may be provided on the distal end 4220 tofurther aid atraumatic advancement of the delivery assembly 4200.

Turning now to FIGS. 47A and 47B, it will be appreciated that the distallocator portion 4202 functions in a manner similar to those disclosed inco-pending application Ser. Nos. 09/732,835 and 10/081,723, thedisclosure of which is expressly incorporated herein by reference. Thatis, the distal locator portion 4202 is selectably controllable betweenan unexpanded state (FIG. 47A) and an expanded state (FIG. 47B). In theunexpanded state, the distal locator portion 4202 has an unexpandedsize; whereas, in the expanded state, it has an expanded size, which isgreater than the unexpanded size in the unexpanded state. The distallocator portion 4202 is configured to expand from the unexpanded size tothe expanded size and/or to contract from the expanded size to theunexpanded size, and the expansion and contraction of the distal locatorportion 4202 preferably is substantially uniform about the longitudinalaxis 4216. For example, one or more expansion elements 4230 can beprovided on the distal locator portion 4202 and can be configured toexpand substantially transversely with respect to a longitudinal axis4216 of the locator portion 4202. Preferably being substantially equallydistributed about an outer periphery 4212 of the distal locator portion4202, the expansion elements 4230 may include radiopaque markers (notshown) or may be wholly or partially formed from a radiopaque materialto facilitate observation of the expansion elements 4230 and/or thedistal locator portion 4202 using fluoroscopy or other imaging systems.

At least one, and preferably all, of the expansion elements 4230 of thedistal locator portion 4202 can comprise a substantially flexible member4230′ with a substantially fixed end region 4230 a′, an intermediateregion 4230 b′, and a movable end region 4230 c′ as shown in FIGS.47A-47B. For each substantially flexible member 4230′, the proximalfixed end region 4230 a′ is fixedly coupled, relatively, with anintermediary support region 4211 separating the distal locator portion4202 from the carrier assembly 4300. In contrast, the movable end region4230 c′ is movably coupled, relatively, with the intermediary supportregion 4211, and configured to be axially movable relative to the fixedend region 4230 a′. When each movable end region 4230 c′ is axiallymoved toward the relevant fixed end region 4230 a′, the intermediateregions 4230 b′ buckle and/or expand transversely outwardly, therebytransitioning the distal locator portion 4202 of the delivery assembly4200 from the unexpanded state to the expanded state. In contrast, thedistal locator portion 4202 transitions from the expanded state to theunexpanded state as each of the movable end regions 4230 c′ are axiallymoved away from the relevant fixed end region 4230 a′.

Hence, the expansion elements 4230 are relatively resilient, and canbuckle without plastic deformation or pure elastic deformation. Further,although the expansion elements 4230 are shown as comprising theflexible members 4230′ in FIGS. 47A-47B for purposes of illustration, itis understood that the expansion elements 4230 can comprise any type ofexpansion elements and are not limited to the illustrated embodiments.For example, inflatable bladder type devices or the like may be employedto cause expansion of the expansion elements, such as a balloon, anexpandable mesh or a slit hypotube, etc. In a preferred embodiment, theflexible members are constructed of nitinol.

Referring back to FIGS. 44 and 47-49, the delivery assembly 4200 alsoincludes the carrier assembly 4300 positioned along the distal end ofthe tubular body 4210, and oriented adjacent and proximate to the distallocator portion 4202. The carrier assembly 4300 is configured to receiveand retain the closure element 4500″ in the slightly expanded,substantially tubular configuration (shown in FIG. 50B), whichpreferably is disposed substantially within the cover member 4330 of thecarrier assembly 4300. The carrier assembly 4300 includes asubstantially cylindrical-shaped carrier seat 4302 configured to seatthe closure element 4500″ thereagainst. By parking the closure element4500″ within the garage tube 4330 (or cover member) during vesseladvancement or positioning, not only is any tissue snaring caused by theclosure element reduced, but the closure element itself is protectedwithin the confines of the cover member.

Turning now to FIGS. 48A-48C, the carrier assembly 4300 preferablyincludes the carrier seat 4302, the pusher member 4320, and the covermember (garage tube) 4330. These components are preferably provided as aplurality of nested, telescoping members with a common longitudinal axis4350. As mentioned, the substantially cylindrical-shaped seat surface orthe carrier seat 4302 is sized and dimensioned to have a transversecross-sectional dimension slightly greater than that of the closureelement 4500″, when the closure element is deformed to its naturalsubstantially tubular configuration. Thus, the closure element 4500preferably is deformed from its natural, planar configuration (FIGS.46A, 46B) to the natural, substantially tubular closure element 4500″(shown in FIGS. 46F, 46G). When being placed or positioned about anouter periphery of the carrier seat 4302, the closure element mustfurther be slightly radially expanded to fit thereover. In thisarrangement, the tines 4520 of the substantially tubular closure element4500″ are pointed substantially distally and ready for tissueengagement. Once seated, the closure element 4500″ will primarily beretained in place using its own resiliency toward the natural planarposition from the slightly expanded, substantially tubular configurationabout the seat surface.

A biocompatible glue or adhesive may further be applied to facilitateretaining the closure element 4500″ on the carrier seat 4302 of thecarrier assembly 4300. Together with the internal restrictive orconfining nature of the cover member 4330, the glue or adhesive must besufficient to overcome the resilient tendency of the closure element4500″ (FIG. 46G) to return to its natural planar condition (FIGS. 46Aand 46B). By way of example, such glues and embedded adhesives includepolymer coatings, Loctite, etc. It will further be appreciated thatother techniques can be applied to retain the closure element 4500″ tothe carrier seat 4302.

In accordance with the present invention, the pusher member 4320 isconfigured to slidably receive at least a portion of the carrier seat4302, as well as the tubular body 4210, with a receiving lumen 4324therein and an external surface 4322 b. The pusher member 4320 is of apredetermined length 4328 a and a predetermined cross-section 4328 b,both of which can be of any suitable dimension. The predetermined length4328 a of the pusher member 4320 can be greater than or substantiallyequal to the collective predetermined length 4218 a and diameter 4218 bof the tubular body 4210 and the carrier assembly 4300. Thepredetermined length 4328 a of the pusher member 4320, however, ispreferably less than the collective predetermined length 4218 a of thetubular body 4210 and the carrier seat 4302, such that a distal endregion 4320 b of the pusher member 4320 is axially offset proximallyfrom the distal end region 4302 b of the carrier seat 4302. This axialoffset, together with the cover member 4330, defines an annular space4360 designated for receipt of the substantially tubular closure element4500″ about the carrier seat 4302.

Being formed from a substantially rigid, semi-rigid, or flexiblematerial, the pusher member 4320 preferably is substantially tubular anddefines receiving lumen 4324 that extends substantially between theproximal end region 4320 a and the distal end region 4320 b. This lumen4324 is configured to slidably receive at least a portion of the tubularbody 4210 and the carrier seat 4302 therethrough. The cross-section 4328b of the pusher member 4320 preferably is substantially uniform, and thedistal end region 4320 b of the pusher member 4320 can comprise one ormore longitudinal extensions 4325, which extend distally from the pushermember 4320 and along the periphery of the carrier seat 4302, as shownin FIG. 48B. The longitudinal extensions 4325 preferably are biased suchthat the longitudinal extensions 4325 extend generally in parallel withcommon longitudinal axis 4350. The longitudinal extensions 4325 aresufficiently flexible to expand radially, and yet sufficiently rigid toinhibit buckling.

As best shown in FIGS. 48A and 48C, the cover member 4330 is configuredto retain the substantially tubular closure element 4500″ and thecarrier assembly 4300 substantially within a lumen 4334 thereof prior todeployment. Being coupled with, and slidable relative to, the carrierseat 4302 and the pusher member 4320, the cover member 4330 has aproximal end region 4330 a and a distal end region 4330 b and includes apredetermined length 4338 a and a predetermined cross-section 4338 b.Preferably being formed as a substantially rigid, semi-rigid, orflexible tubular member formed from a polymer, the cover member 4330 hasan outer periphery 4332 b and an inner periphery 4332 a that defineslumen 4334. The lumen 4334 extends substantially between the proximaland distal end regions 4330 a, 4330 b of the cover member 4330 and canbe configured to slidably receive at least a portion of the pushermember 4320. When the cover member 4330 is properly positioned over thepusher member 4320 and the carrier seat 4302, the distal end region 4330b is configured to extend over the space 4360, thereby defining anannular cavity for receiving and retaining the closure element 4500″ inthe substantially tubular configuration.

In one preferred embodiment, as best illustrated in FIGS. 48A, 48C, 50Band 50C, one or more longitudinal extensions 4335 extend distally fromthe garage tube or cover member 4330. Although the longitudinalextensions 4335 can extend generally in parallel with commonlongitudinal axis 4350, the longitudinal extensions 4335 preferably arebiased such that the plurality of longitudinal extensions 4335 extendsubstantially radially inwardly as illustrated in FIGS. 48A and 48C.Thereby, the longitudinal extensions 4335 can at least partially closethe annular space 4360 slotted for seating of the closure element 4500″.

The cross-section 4338 b of the cover member 4330 preferably issubstantially uniform. In the embodiment of FIGS. 44, 45 and 47-51, thedistal end region 4330 b of the cover member 4330 is integrated with thetissue engaging device 4400, as will soon be detailed. To permit thesubstantially tubular closure element 4500″ to be deployed from theannular space 4360, the cover member 4330 can be slidably retracted,relative the carrier seat 4302 to expose the mounted closure element4500″.

If the carrier assembly 4300 is assembled as a plurality of nested,telescoping members as shown in FIG. 48A, the tubular body 4210 of thedelivery assembly is at least partially disposed within, and slidablerelative to, the lumen 4324 of the pusher member 4320. The pusher member4320, in turn, is at least partially disposed within, and slidablerelative to, the lumen 4334 of the cover member 4330. Hence, thelongitudinal axis 4216 of the locator portion 4202, the carrier assembly4300 and the tubular body 4210 (i.e., of the delivery assembly 4200) arepreferably substantially in axial alignment with the common longitudinalaxis 4350 of the pusher member 4320 and the cover member 4330.

In accordance with this embodiment of the present invention, the tissueengaging device 4400 is disposed and oriented on the distal end of thecover member 4330 for operation between the tissue engaging condition(FIGS. 51D, 51E) and the tissue closing condition (FIGS. 51F, 51G). Aspreviously indicated, in the tissue engaging condition, the tissueengaging device 4400 engages the opposing arterial walls 4620′, 4620″(e.g., FIG. 51E) of the vessel 4600 adjacent to the opening 4610 so thatthey can be pulled or urged radially inward or transversely toward oneanother in the closing condition (FIG. 51F). In the closing condition,hence, the engaging device 4400 urges the opposing arterial walls 4620′,4620″ at the vessel opening 4610, substantially radially together aboutaxis 4216 and toward one another. By closing the opposing arterial wallswithin the first diameter of the closure element 4500″, the closureelement can be deployed directly from the carrier seat 4302 of thecarrier assembly 4300 without having to further radially expand tosufficiently engage the tissue.

As best illustrated in FIG. 50B, the engaging device 4400 includes atleast two opposing tongs 4402, each of which extends distally from thedistal end of the cover member and terminates at a tissue engaging tip4404. The tips 4404 may be conventionally pointed shaped that facilitatepenetration and/or snaring of tissue during operation. These tongs,preferably integral with the cover member or garage tube 4330, aresufficiently flexible to enable control and operation in and by the GFsheath 4640, yet are sufficiently rigid to enable extravascularpenetration, snaring and/or grasping of the target arterial wall. In onespecific configuration, for example, the distal end of the garage tubemay be fabricated from a material having shape memory properties where,in use, the combined subsystem would cooperate the GF sheath 4640 tooperate and control the use of the tissue engaging device 4400.

The two or more tongs 4402 of the tissue engaging device 4400 areconfigured and oriented for sliding reciprocal cooperation with aninterior wall 4642 of the sheath 4640 to control movement and operationof the engaging device between the tissue engaging condition (FIGS. 51D,51E) and the closing condition (FIGS. 51F, 51G). More specifically, thedistal tips 4404 of each tong 4402, in the tissue engaging condition,will be manipulated to snare and/or engage the arterial walls 4620′,4620″ being held taut by the tissue locator portion 4202, in theexpanded condition. Preferably, the engaging device distal tips 4404will be radially expanded or oriented at least as wide as the firstdiameter, relative to longitudinal axes 4216, 4350, of the closureelement seated about the carrier seat 4302. More preferably, the distaltips 4404 will be radially expanded to a disposition greater than andbeyond the first diameter to ensure sufficient snaring and/or engagingof the arterial walls surrounding the vessel opening 4610. Accordingly,the tongs of the tissue engaging device are biased and/or have adisposition extending radially outward. Hence, by retracting therestrictive sheath 4640 proximally relative to the garage tube 4330 (oradvancing the delivery assembly distally past the distal end of thesheath), the respective tongs 4402 of the tissue engaging device 4400will be released and permitted to radially expand to the tissue engagingposition (FIG. 51D).

Briefly, as will be described in greater detail below, once the arterialwalls 4620′, 4620″ are snared or pierced by the tissue engaging device4400, in the tissue engaging condition, the GF sheath can be displaceddistally, relative to the garage tube. Sliding contact between theinterior wall 4642 of the sheath and the outer facing surfaces 4406 ofthe tongs 4402 causes the distal tips of the engaging device to draw thetissue radially inward toward one another (FIG. 51F). As the interiorwall 4642 of the sheath is advanced distally, the increasing contactalong the outer surfaces 4406 of the tongs causes the distal tips toinvert inwardly within the first diameter of the closure element in thesubstantially tubular configuration about the carrier seat 4302, in theclosing condition.

FIG. 49 best illustrates that the clip applier apparatus 4100 includes ahousing/handle 4380 at a proximal end thereof suitable for gripping andmanual support, manipulation and operation of the device and componentsthereof. Preferably, the housing 4380 is an elongated member having aproximal end 4380 a and a distal end 4380 b with a longitudinal axis4386. When the apparatus 4100 is properly assembled, the tube set 4305of the delivery assembly 4200 is at least partially disposed within thehousing handle such that the pusher member 4320 and the cover member4330 are slidable relative to the housing 4380, the tubular body 4210,the carrier seat 4302 and the distal locator portion 4202 thereof.Further, respective distal end regions 4210 b, 4320 b and 4330 b extendfrom the distal end region 4380 b of the housing 4380 such that thecommon longitudinal axis 4350 (shown in FIG. 48A) of the tube set 4305is substantially axially aligned with the longitudinal axis 4386 of thehousing 4380. Being configured to slidably retain the respectiveproximal end regions 4210 a, 4320 a and 4330 a, the housing 4380supports the tube set 4305 and can have one or more handles 390 tofacilitate use of the apparatus 4100. The handles 4390 extendsubstantially radially from the outer periphery 4382 of the housing 4380and can be provided in the manner known in the art.

The present invention incorporates various switching systems, triggeringsystems, locking systems, etc. contained in the handle portion to effectuse and operation of the delivery components described herein. While allthese subsystems are not shown and described herein in detail, it willbe appreciated that they are similar to the design and operation of theanalogous subsystems shown and described in our '214 patent application,which as mentioned is incorporated by reference herein for all purposes.

By way of example, however, the locator portion 4202 also can include alocator control system 4240 that is coupled with the proximal end region4210 a of the delivery assembly 4200 and that is configured toselectively control the distal locator portion 4202 between theunexpanded and expanded states (FIG. 47C). The locator control system4240 can selectively control the distal locator portion 4202 between theunexpanded and expanded states, such as by being activated by aswitching system (not shown). For example, a control member 4250, suchas a rod, wire, or other elongate member, can be moveably disposedwithin a lumen (not shown) formed by the tubular body 4210 and extendingsubstantially between the proximal end region 4210 a of the tubular body4210 and the distal locator portion 4202. The control member 4250 has aproximal end region 4250 a that is coupled with the locator controlsystem 4240, preferably through a control block (not shown, butoperationally similar to the control systems and structures), and adistal end section (not shown) of the control member 4250 that iscoupled with the expansion elements 4230, and/or the movable end regions4230 c′ of the substantially flexible members 4230′. The locator controlsystem 4240 can selectively transition the expansion elements 4230,and/or the substantially flexible members 4230′ of the distal locatorportion 4202 between the unexpanded and expanded states by moving thecontrol member 4250 axially relative to the tubular body 4210.

The locator control system 4240 preferably includes a locator releasesystem (not shown, but one embodiment which may be similar to thatdisclosed in the '214 patent application) for maintaining the unexpandedstate and/or the expanded state of the distal end region 4210 b, theexpansion elements 4230, and/or the substantially flexible members4230′. The locator release system is preferably configured to maintainthe locator portion in the expanded state. Any type of locking systemcan be employed, and can be engaged, for instance, by activating theswitching system. For example, once the substantially flexible members4230′ have entered the expanded state, the locator release system cansecure the control member 4250 to prevent axial movement relative to thetubular body 4210, thereby maintaining the substantially flexiblemembers 4230′ in the expanded state.

The locator control system 4240 also can be configured to disengage thelocator release system, such that the distal end region 4210 b, theexpansion elements 4230, and/or the substantially flexible members 4230′can transition between the unexpanded and expanded states. The locatorrelease system can be disengaged, for example, by activating anemergency release system (not shown). As desired, the locator controlsystem 4240 can further include a biasing system (not shown), such asone or more springs, to bias the distal end region 4210 b, the expansionelements 4230, and/or the substantially flexible members 4230′ to enterand/or maintain the unexpanded state when the locator release system isdisengaged.

In use, the closure element 4500″ is carried on the carrier seat 4302,in the slightly radially expanded tubular configuration, and is disposedwithin the cover member 4330. As shown in FIGS. 50A-50C, for example,the closure element 4500″ can be slidably received over the distallocator portion 4202 and the distal end region of the carrier assembly4300. The closure element 4500″ is then seated and disposed about theperiphery of the carrier seat 4302 adjacent to the space 4360, in theslightly expanded, substantially tubular configuration.

After being received over the distal end region 4302 b, thesubstantially tubular closure element 4500″ is disposed in the space4360, and the tines 4520 are directed substantially distally as shown inFIG. 50B. To improve the engagement between the closure element 4500″(shown in FIGS. 46A-46B) and the blood vessel wall 4620 and/or tissue4630 (collectively shown in FIG. 51A), the substantially tubular closureelement 4500″ preferably is disposed on the carrier seat 4302 such thatthe tines 4520 are contained in a plane.

Once disposed in the space 4360, the resiliency of the slightly expandedclosure element 4500″ and/or the addition of an adhesive or glue willfacilitate retention of the element in place about the carrier seat.Moreover, the sliding receipt of the substantially tubular closureelement 4500″ and the distal end region 4320 b of the pusher member 4320within the lumen 4334 of the cover member 4330, as illustrated in FIGS.50B and 50C, also cooperate to retain the closure element 4500″ againstthe carrier seat 4302. When the cover member 4330 is properly positionedover the carrier assembly 4300, the distal end region 4330 b (oppositeof the proximal end region 4330 a) of the cover member 4330 extends overthe space 4360 and defines the annular cavity for retaining thesubstantially tubular closure element 4500″. As such, the closureelement 4500″ is disposed substantially between the outer periphery ofthe carrier seat 4302 and the inner periphery 4332 a of the cover member4330 such that the substantially tubular closure element 4500″ maintainsthe substantially tubular configuration with the tines 4520 beingdirected substantially distally. As desired, the tube set 4305 mayslightly radially compress the substantially tubular closure element4500″ to facilitate seating against the carrier seat. The body 4510 ofthe substantially tubular closure element 4500″ can be disposed distallyof the distal end region 4320 b of the pusher member 4320, asillustrated in FIG. 50C, or can engage the distal end region 4320 b, asdesired.

Turning now to FIGS. 51A-51H, operation of this specific embodiment willnow be detailed. Initially, introducer sheath 4640 may be inserted orotherwise positioned through skin 4650 and tissue 4630 and within theblood vessel 4600 or other body lumen via the opening 4610. Comprising asubstantially flexible or semi-rigid tubular member, the sheath 4640 hasa proximal end region 4640 a and a distal end region 4640 b and includesa predetermined length and a predetermined cross-section, both of whichcan be of any suitable dimension. The sheath 4640 also forms aperipheral surface 4645 and a lumen 4644 that extends along alongitudinal axis of the sheath 4640 and substantially between theproximal and distal end regions 4640 a, 4640 b. The lumen 4644 can haveany suitable internal cross-section 4648 b and is suitable for receivingone or more devices (not shown), such as a catheter, a guide wire, orthe like. The lumen 4644 is configured to slidably receive tube set 4305and the delivery assembly 4200 of the apparatus 4100, including thenested tubular body 4210, the carrier seat 4302, the distal locatorportion 4202, pusher member 4320 and the cover member 4330 as a singleunit. Accordingly, one significant advantage of the present invention isthat, due to the reduced complexity of the cooperating componentry, theoverall diametric footprint can be significantly smaller relative to thecurrent systems. Hence, the entire nested tube set 4305 may be slidablyreceived in the lumen 4644 of the introducer sheath 4640 withoutrequiring a radial expansion or splitting of the sheath 4640. Such aconfiguration is beneficial in that, when required, the deliveryassembly 4200 can be retracted and reinserted unlike the previousdesigns that irreversibly radially expanded, stretched, split or severedthe analogous sheaths.

The introducer sheath 4640 may be advanced over a guide wire or otherrail (not shown) that was previously positioned through the opening 4610and into the blood vessel 4600 using conventional procedures. In onespecific use, the blood vessel 4600 is a peripheral blood vessel, suchas a femoral or carotid artery, although other body lumens may beaccessed using the sheath 4640 as will be appreciated by those skilledin the art. The opening 4610, and consequently the sheath 4640, may beoriented with respect to the blood vessel 4600 such as to facilitate theintroduction of devices through the lumen 4644 of the sheath 4640 andinto the blood vessel 4600 with minimal risk of damage to the bloodvessel 4600. One or more devices (not shown), such as a catheter, aguide wire, or the like, may be inserted through the sheath 4640 andadvanced to a predetermined location within the patient's body. Forexample, the devices may be used to perform a therapeutic or diagnosticprocedure, such as angioplasty, atherectomy, stent implantation, and thelike, within the patient's vasculature.

After the procedure is completed, the devices are removed from thesheath 4640, and the apparatus 4100 is prepared to be slidably receivedby the lumen 4644 of the sheath 4640 as shown in Figure MB. Being in theunexpanded state, the distal end region of the distal locator portion4202, via tubular body 4210, is slidably received by the lumen 4644 andatraumatically advanced distally into the blood vessel 4600 (FIG. 51B).Briefly, it will be appreciated that, due to the fixed configurationbetween the distal end region of the carrier assembly 4300 and theproximal end region of the distal locator portion 4202, in a supportconfiguration, that the carrier seat 4302, the pusher member 4320 andthe cover member 4330, together with the closure element in the slightlyexpanded, substantially tubular configuration, are also advanceddistally near the blood vessel 4600 as a unit. Moreover, since thepusher member 4320 and the cover member 4330 are also coupled to thetubular body 4210, those components are likewise advanced distallytogether with the locator portion 4202. Once the distal end region ofthe distal locator portion 4202 extends into the blood vessel 4600, thedistal locator portion 4202 can transition from the unexpanded state(FIG. 51B) to the expanded state (FIG. 51C) by activating the switchingsystem of the locator portion 4202.

Turning now to FIG. 51D, the apparatus 4100 and the sheath 4640 then areretracted proximally until the distal end region of the locator portion4202 is substantially adjacent to an inner surface 4620 b of the bloodvessel wall 4620. The distal end region of the locator portion 4202thereby draws the opposing blood vessel walls 4620′, 4620″ taut andmaintains the proper position of the apparatus 4100 as the blood vessel4600 pulsates. Since the expanded cross-section of the expansionelements 4230 is collectively greater than or substantially equal to thecross-section of the opening 4610 and/or the cross-section of the lumen4644, the expansion elements remain in the blood vessel 4600 and engagethe inner surface 4620 b of the blood vessel wall 4620. The expansionelements 4230 can frictionally engage the inner surface 4620 b of theblood vessel wall 4620, thereby securing the apparatus 4100 to the bloodvessel 4600. The sheath 4640 is then retracted proximally such that thedistal end region 4640 b of the sheath 4640 is substantially withdrawnfrom the blood vessel 4600, as shown in FIG. 51D, permitting theapparatus 4100 to access the blood vessel wall 4620.

While the relative distance between the distal end region of the carrierassembly 4300 (i.e., the carrier seat 4302) and the proximal end regionof the distal locator portion 4202 is preferably substantially fixed, itwill be appreciated that such relative distances can be non-fixed aswell. More particularly, upon establishing a first position of FIG. 51D,the carrier seat 4302 and the loaded closure element 4500″, in thesubstantially tubular configuration, are disposed proximal andsubstantially adjacent to the outer surface 4620 a of the blood vesselwall 4620. In this manner, the blood vessel wall 4620, adjacent to theopening 4610, is disposed substantially between the expanded distalregion of the locator portion 4202 and the distal end region of thecarrier assembly 4300.

Hence, once the distal end region of the locator portion 4202 properlyengages the inner surface 4620 b of the blood vessel wall 4620 as theexpansion elements 4230 are selectively positioned and moved to theexpanded state, the sheath 4640 is further retracted proximally,exposing the tongs 4402 of the tissue engaging device 4400. Asmentioned, the interior walls 4642 of the sheath 4640 cooperate with thegarage tube 4330 to maintain a substantially cylindrical profile, and tocontrol and operate the use tongs 4402 of the distal tissue engagingdevice, which are substantially distally facing and flush against thetubular body 4210 when contained in the sheath 4640. Further proximalretraction of the sheath 4640 exposes the tongs 4402 of the tissueengaging device 4400 from inside the sheath lumen 4644, allowing thedistal tips 4404 of the tongs to radially expand toward the engagingcondition.

Depending upon the particular design of the tissue engaging device 4400,movement of the distal tips 4404 of the tongs may occur in differentways. For instance, if the tissue engaging device 4400 is composed of ashape memory material, exposure of the heat set tissue engaging device4400 to the tissue environment causes radial expansion of the tongs 4402toward the engaging condition. In contrast, in a resilient, elbowed-typeconfiguration of the engaging device tongs 4402, as shown in FIGS.51B-51E, proximal retraction reduces the compressive contact of theexterior facing surfaces of the engaging device tongs 4402 with theinterior wall 4642 of the sheath 4640. This allows the distal tips 4404of the tongs to radially expand toward the engaging condition.

Once the tissue engaging device 4400 has radially expanded to the tissueengaging condition, the garage tube 4330 can be axially advanceddistally, relative to the carrier assembly 4300 and the tissue locatorportion 4202, maintaining the closure element 4500″ seated in thecarrier seat 4302 (not shown). It will be appreciated, however, that thetube set 4305, with the exception of the tubular body 4210, can beaxially advanced along the tubular body together as a unit, as bestviewed in FIG. 51E. Hence, as the cover member is advanced distally, sois the pusher member 4320 that unseats the closure element 4500″ fromthe carrier seat 4302 about the tubular body 4210. Consequently, thedistal tips 4404 of the tongs, oriented distally toward arterial walls4620′, 4620″ that define the vessel opening 4610, are extravascularlyadvanced into piercing or snaring contact therewith. In cooperation withthe expansion elements 4230 of the distal locator portion 4202, in theexpanded condition, the arterial walls are maintained taut to facilitateengagement by the tongs.

Referring now to FIG. 51F, the tissue engaging device 4400 at the distalend of the garage tube 4330 is collapsed together in the closingcondition. This is performed by sliding the sheath 4640 distally,relative to the carrier assembly 4300 and the tissue locator portion4202 (or retracting the garage tube 4330 into the sheath 4640),increasing contact and engagement of the tongs 4402 with the lumeninterior wall 4642 of the sheath. In effect, the sliding contact pinchesthe distal tips 4404 of the tissue engaging device tongs 4402 together,pulling the opposed arterial walls 4620′, 4620″ radially inward towardthe closing condition (i.e., within the first diameter of the closureelement).

During operation of the tissue engaging device from the tissue engagingcondition to the closing condition, the substantially tubular closureelement 4500″ is advantageously retained on the outer periphery of thecarrier seat 4302 by the cover member 4330 as illustrated in FIG. 51E.By retaining at least the proximal portion of the substantially tubularclosure element 4500″ between the distal end region (e.g., the radially,inwardly directed longitudinal extensions 4335) of the cover member 4330and the distal end region of the carrier seat 4302, the apparatus 4100is configured to provide better tissue penetration for the seatedclosure element 4500″.

As mentioned, in one specific embodiment, the carrier seat 4302 and thecover member 4330 of the carrier assembly 4300 cooperate to maintain thesubstantially tubular closure element 4500″ in the tubularconfiguration, and fixed relative to the distal tissue engaging device4400. After the tissue engaging device 4400 engages the opposed arterialwalls 4620′, 4620″ in the closing condition (FIG. 51F), the locatorrelease system (not shown) can be activated to transition the expansionelements 4230 of the tissue locator portion or obturator 4202 from theexpanded state to the unexpanded state, as shown in FIG. 51G.

The proximal end region of the locator portion 4202 can be retractedproximally, effectively retracting the tubular body 4210 and the distallocator portion 4202 into the lumen 4324 of the pusher member 4320, andrelative to the garage tube 4330, closure element 4500″ and sheath 4640(FIG. 51G). Simultaneously, the distal end of the pusher member 4320 canbe advanced distally, contacting the closure element 4500″ and advancingit distally and axially along the tubular body 4210 of the deliveryassembly 4100 and toward the tissue locator portion 4202. Once thedistal end region of the tissue locator portion 4202 is axiallyproximate to the closure element 4500″ (e.g., seated about the expansionelements 4230 of the tissue locator portion), the closure element isnearly ready to be deployed. The tissue locator portion 4202 and thecover member 4330 preferably are inhibited from further relative axialmovement and remain substantially stationary, relative the handleportion; whereas, the pusher member 4320 remains axially slidable. Asthe pusher member 4320 selectively continues distally, the distal endregion 4320 b of the pusher member 4320 further engages thesubstantially tubular closure element 4500″ and displaces it from itsseating about the expansion elements 4230 of the obturator (FIG. 51G).

In accordance with the present invention, the closure element 4500″,seated about the delivery assembly 4200 in the slightly expanded,substantially tubular condition, is delivered into engagement with theopposed blood vessel arterial walls 4620′, 4620″ and/or tissue 4630adjacent to the opening 4610 without further radial expansion thereof.As previously indicated, this benefit is due to the fact that the tissueengaging device 4400 is simultaneously engaged with the vessel wall4620, and draws the opposed engaged side walls 4620′, 4620″ radiallyinward relative to one another and within the first diameter of theclosure element.

Upon being advanced over the distal locator portion 4202, in theunexpanded state, by the pusher member 4320, the substantially tubularclosure element 4500″ is distally deployed as illustrated in FIG. 51G.Continued distal advancement of the pusher member 4320 past the distalend of the obturator delivers the tongs 4402 of the closure element4500″ into piercing engagement with the arterial walls 4620′, 4620″surrounding the vessel opening. When the substantially tubular closureelement 4500″ is deployed, the tines 4520 can pierce and otherwiseengage a significant amount of the blood vessel wall 4620 and/or tissue4630 adjacent to the opening 4610 without requiring significant furtherradio expansion in order to sufficiently engage the walls. Due to thesimultaneous engagement of the tissue engaging device 4400 with thevessel walls, the tines 4520 can engage a significant amount of theopposed blood vessel arterial walls 4620′, 4620″ and/or tissue 4630because the vessel walls 4620′, 4620″ are pulled together by theengaging device, in the closing condition. In particular, the tongs 4402of the tissue engaging device 4400 engage the opposed vessel walls4620′, 4620″, and urge them radially inwardly, within the first diameter(and hence within the cross-section 4530) of the substantially tubularclosure element 4500″ simultaneously while the pusher member 4320 isdeploying the closure element.

Once the substantially tubular closure element 4500″ is deployed (FIG.51H), it begins to transition from the tubular configuration to thenatural, planar configuration with opposing tines 4520 and a naturalcross-section 4530 of the closure element 4500″. Preferably, thesubstantially tubular closure element 4500″ substantially uniformlytransitions from the tubular configuration to the natural, planarconfiguration. Rotating axially inwardly to form the opposing tines 4520of the closure element 4500″, the tines 4520 draw the tissue 4630 and/oropposing vessel walls 4620′, 4620″ into the channel 4540 of thetransitioning closure element 4500″. In addition, the tissue 4630 isdrawn substantially closed and/or sealed as the cross-section 4530′ ofthe substantially tubular closure element 4500″ contracts to return tothe natural cross-section 4530 of the closure element 4500. Thereby, theopening 4610 in the blood vessel wall 4620 can be drawn substantiallyclosed and/or sealed via the closure element 4500 as illustrated in FIG.51H. Subsequently, the sheath 4640 and the tube set 4305 of the deliveryassembly 4200 can be withdrawn from the tissue 4630.

To reduce interference of the closure element tines 4520 with the tissueengaging tongs, while the tongs are engaged with the vessel walls 4620′,4620″ in the closing condition, the tips 4404 and the tongs 4402 can beconfigured so as to be angularly off-set (at virtually any angleresulting in non-interference) from one another (not shown) about thecommon longitudinal axis 4350. For example, as little as about a 5degrees angular off-set between the engaging device tongs 4402 and theclosure element tines 4520, about the common longitudinal axis 4350,will significantly reduce contact of the tines with the tongs duringdelivery of the closure element.

Turning now to FIGS. 52 and 53, an alternative embodiment deliveryassembly 4200 is illustrated wherein the tissue engaging device 4400 isdisposed within and deployed from a central lumen 4204 of the tubularbody 4210. As indicated above, the primary difference between thevarious embodiments of the present invention is the location,implementation and execution of the tissue engaging device 4400. Forexample, in this embodiment, the tissue engaging device 4400 isconfigured to intravascularly engage the opposing arterial walls 4620′,4620″, while in the previous embodiment, the tissue engaging deviceextravascularly engages the arterial walls.

The primary orientation and operation of the remaining components of thedelivery assembly 4200, however, are similar to the previously discussedembodiments. That is, the delivery assembly 4200 contains a similar tubeset 4305 consisting of the locator portion 4202 and the carrier assembly4300, the carrier assembly of which is located at the distal end of thetubular body 4210, just proximal to the locator portion 4202. Briefly,the carrier assembly 4300 similarly consists of the carrier seat 4302,the tubular pusher member 4320 and a nested garage tube 4330; the latterof which surrounds the former two, and all of which are coaxial withlongitudinal axis 4216 of the tubular body 4210.

The tissue locator portion 4202 includes a tubular bleed back shaft 4260distally extending from a distal end of the carrier seat 4302.Preferably, both the carrier seat and the bleed back shaft 4260 areintegrally formed with one another on the end of the delivery assemblytubular body 4210. The bleed back shaft 4260 includes a bleed back port4262 that functions to locate the vessel opening 4610 at puncture sitein the vessel 4600. This port 4262 is oriented a predetermined distancefrom the distal end from the bleed back shaft 4260. The bleed back port4262 communicates with a bleed back lumen (not shown) thatlongitudinally extends from the locator portion and through the tubularbody 4210 of the delivery assembly, although it will be appreciated thatthe port could also share a lumen with the tissue engaging device.

In accordance with this specific embodiment, the cover member or garagetube 4330 similarly covers the pusher member 4320, the carrier seat 4302of the carrier assembly 4300, and the tubular body 4210 (i.e., tube set4305). Since the tissue engaging device is not disposed at the distalend of the garage tube, the annular distal end preferably terminatesjust distal to the carrier seat 4302, defining the annular space 4360that seats the closure element 4500″ in the substantially tubularconfiguration. In one preferred embodiment, one or more longitudinalextensions extend distally from the garage tube or cover member 4330,similar to extensions 4355 of FIG. 50B. Although these longitudinalextensions can extend generally in parallel with common longitudinalaxis 4350, the longitudinal extensions preferably are biased such thatthey extend substantially radially inwardly. Thereby, the longitudinalextensions can at least partially close the central lumen 4334substantially adjacent to the distal end region of the cover member4330.

Referring back to FIG. 52, in operation, the tube set 4305 of thedelivery assembly 4200 of the clip applier apparatus 4100 is advancedthrough the sheath lumen 4644 of the sheath 4640 using similartechniques to those shown and described in FIGS. 51A and 51B. When thetissue locator portion 4202 locates the vessel opening 4610 and thebleed back shaft 4260 is inserted into the body vessel 4600 to thepredefined depth, the bleed back port 4262 communicates with fluid flow,hence locating the vessel opening 4610.

Once tissue locator portion 4202 is properly oriented, the tissueengaging device 4400 can be distally deployed from a distal end of thetubular body 4210. As shown in FIGS. 53 and 54, the tissue engagingdevice 4400 is slidably disposed within a lumen 4204 of the tubular body4210. This lumen 4204 further extends through the carrier assembly 4300and the locator portion 4202, terminating at an end port 4264 at thedistal end thereof. The tissue engaging device 4400 includes one or moretongs 4410 having proximal end regions associated with a common controlshaft (not shown) operated at the handle portion 4380 of the clipapplier apparatus 4100. Each resilient tong 4410 is naturally bowed in aU-shaped manner such that when continually distally advanced from thetubular body end port 4264, each tong resiliently bows radiallyoutwardly from common axis 4216, and bows upwardly toward the interiorsurface 4620 b of the opposing arterial walls 4620′, 4620″. As the tongs4410 of the tissue engaging device are further deployed, the tips 4412(e.g., barbed tips) of the tongs 4410 are configured to intravascularlypierce, snare or grab the arterial walls 4620′, 4620″ from the undersidesurface 4620 b surrounding the puncture site (i.e., in a tissue engagingcondition of FIG. 52). The snaring, piercing and/or grabbing of thearterial walls could be accomplished by hooks, barbs, or similar on theends of the tongs 4410. The piercing from the underside surface,furthermore, may be accomplished by the curved shape of the tongs 4410as they exit the distal end of the bleed back shaft 4260.

Accordingly, the resilient tongs 4410 are sufficiently flexible forsliding reciprocal receipt in the receiving lumen 4204 of the tubularbody 4210 of the delivery assembly 4200, yet sufficiently rigid toenable piercing, snaring or grabbing of the arterial walls when engagedtherewith. Such materials exhibiting these characteristics, for example,include Nitinol and stainless steel.

Once the opposing arterial walls 4620′, 4620″ are sufficiently grasped,snared or penetrated, the tubular body 4210 of the delivery assembly4200 is retracted extravascularly through the receiving lumen 4204 ofthe pusher member 4320. This operation is performed while the garagetube 4330, the closure element 4500″ and the pusher member 4320 aresubstantially axially maintained at their position relative to thevessel opening 4610 of the body vessel 4600. Accordingly, the relativemovement between the tubular body 4210 and the pusher member 4320, inturn, unseats the closure element 4500″ from the carrier seat 4302 andadvances it toward the distal end of the tubular body 4210. Alone or incombination with the above tubular body retraction, the tongs 4410 ofthe tissue engaging device 4400 may also be retracted into the receivinglumen 4204 of the tubular body 4210. As the tubular body 4210 and/or thetongs 4410 are being retracted, the arterial walls 4620′, 4620″ arepulled together radially inward until they are disposed within the firstdiameter of the closure element 4500″, in a closing condition (FIG. 53).Continued retraction further urges the engaged opposing arterial walls4620′, 4620″ radially together under the bleed back shaft and into thechannel 4540 defined by the substantially tubular closure element 4500″.

To permit the substantially tubular closure element 4500″ to be deployedfrom the annular cavity 4360, the cover member 4330 can also be slidablyretracted, relative the tubular body 4210. The longitudinal extensions4335 of the cover member 4330 preferably are sufficiently flexible toexpand radially to permit retroactive movement of the distal end regionof the cover member 4330 peripherally over the mounted closure element4500″. This opens the annular cavity 4360 such that the distal endregion of the cover member 4330 no longer fully encloses the closureelement.

Turning now to FIG. 54, the pusher member 4320 is then advanced distallyto deploy the closure element 4500″. Similar to the technique appliedabove, the tines 4520 of the closure element 4500″ pierce the opposingarterial walls 4620′, 4620″ that are radially pulled together, via thetissue engaging device 4400 in the closing condition, within the firstdiameter. Once the substantially tubular closure element 4500″ isdeployed, it begins to transition from the tubular configuration to thenatural, planar configuration with opposing tines 4520 and a naturalcross-section 4530 of the closure element 4500 (substantially similar tothe deployment of the closure element detailed and shown in FIGS. 51Gand 51H). The arterial walls 4620′, 4620″ are drawn substantially closedand/or sealed as the cross-section 4530′ of the substantially tubularclosure element 4500″ contracts to return to the natural cross-section4530 of the closure element 4500. Thereby, the opening 4610 in the bloodvessel wall 4620 can be drawn substantially closed and/or sealed via theclosure element 4500, as illustrated in FIG. 51H. Subsequently, thetongs 4410 of the tissue engaging device 4400 are retracted in the bleedback shaft 4260, and the delivery assembly 4200 and sheath 4640 can beremoved.

It will be appreciated that the bleed back shaft 4260 is composed of amaterial that reduces sticking of the tines 4520 of the closure elementduring deployment, should any contact ensue. This would be detrimental,of course to the proper clip deployment. Essentially, the compositionshould be at least as hard as the tines of the closure element so as notto stick into the bleed back shaft itself. Beneficial shaft compositionsinclude any hard material that can be formed into a tube and is alsobiocompatible, such as stainless steel and Nitinol to name a few.Further, similar to the embodiments above-mentioned, the seating of theclosure element 4500″ about the carrier seat 4302 is in a mannerangularly off-setting the closure element tines 4520 (relative to thelongitudinal axis 4216) from the angular position of the tissue engagingtongs 4410, to reduce interference during deployment of the closureelement.

FIGS. 55 and 56 represent another specific embodiment clip applierapparatus 4100 incorporating a tissue engaging device 4400 thatintravascularly engages the opposing arterial walls 4620′, 4620″. Inaccordance with this specific embodiment, however, the analogous tongs4410 cooperate to radially push the engaged opposing arterial wallstogether as opposed to radially pulling them together, as does theembodiment disclosed in FIGS. 52-54. As best illustrated in FIG. 55, thetongs 4410 of the tissue engaging device 4400, in their naturalconfiguration, are substantially C-shaped. For each tong 4410, therespective distal tip 4412 is configured to loop nearly all the wayaround onto itself. That is, in their respective own plane substantiallyintersecting the longitudinal axis 4216 of the bleed back shaft 4260,the distal tip of each tong loops back around from the end port 4264 ofthe bleed back shaft 4260. Briefly, it will be appreciated that naturalloop shape of each tong neither needs to be exactly circular, nor becurvilinear for that matter, as long as the tip 4412 extends back aroundin a direction toward the longitudinal axis 4216 of the shaft 4260.

Again, using similar placement and advancement techniques through thesheath lumen 4644 of the sheath 4640, as shown and described in FIGS.51A and 51B, the tube set 4305 of the delivery assembly 4200 can bepositioned near the vessel opening 4610. Once the tissue locator portion4202, via bleed back port 4262, has determined the location and properdepth of insertion of the bleed back shaft 4260 into the vessel opening4610 of the vessel body 4600, the two or more tongs 4410 are advanceddistally out of the shaft end port 4264, via controls at the handlemember 4380 (FIG. 49). As the advancement of the tongs 4410 of thetissue engaging device 4400 distally continue, the tips 4412 of thetongs 4410 continue to loop back around until they grip, snag and/orpartially pierce the underside surface 4620 b of the opposing arterialwalls 4620′, 4620″ (in a manner similarly described in the operation ofthe embodiment of FIGS. 52 and 53.

Once the arterial walls 4620′, 4620″ are sufficiently initially engaged,further advancement of the tongs from the distal end port 4264 of thebleed back shaft 4260 causes the tong tips 4412 to return to theirnatural state, in their respective plane (i.e., directed back towardlongitudinal axis 4216 of the bleed back shaft 4260). In effect, theengaged opposed arterial walls 4620′, 4620″ are pushed together by theadvancing tong tips 4412, which return to their natural state, until theedges 4622′, 4622″ of the opposing arterial walls 4620′, 4620″ contactthe exterior surface of the bleed back shaft 4260. Accordingly, unlikethe previous embodiment, the engaged opposing arterial walls 4620′,4620″ are urged together without retracting the bleed back shaft 4260and/or retracting the tongs 4410 back into the receiving lumen 4204.This is beneficial in that it allows the user to continue monitoring theproper location of the device. Further, by not retracting the tongs, thechance that the tongs dislodge from the arterial walls decreases priorto deployment of the closure element.

Accordingly, the tips 4412 of the respective tongs 4410 are configuredto not fully penetrate the engaged opposing arterial walls 4620′, 4620″or each tong may experience difficulty urging and pushing the opposingwalls back toward and against the bleed back shaft. For example, the tipconfiguration can be more blunted, radiused or roughened, so as topartially pierce the tissue, but not fully penetrate it.

Regarding the resilient tongs 4410, they must be capable of sufficientflexibility to unfold from their naturally curved and hookedconfiguration to a substantially straight configuration when housed orstored within the lumen 4204 of the tubular body 4210. However, thetongs 4410 of the tissue engaging device 4400 must also be sufficientlystiff, strong and resilient to push the engaged arterial walls together,and back against the bleed back shaft 4260 when the tongs are fullydeployed from the distal end of the bleed back shaft 4260. Suchmaterials for each tong 4410, for example, may include Nitinol andstainless steel.

Since the opposed arterial walls 4620′, 4620″ must be pushed, as opposedto pulled, radially together to an orientation within the first diameterof the seated closure element 4500″, the diameter of the bleed backshaft 4260 at the region of contact by the edge 4622′, 4622″ of thearterial walls 4620′, 4620″ is reduced from that of the carrier seat4302. Such a diameter reduction, relative to the carrier seat, increasesthe width of tissue engagement about by the tines 4520 of the closureelement 4500″, about the vessel opening 4610, by enabling the opposedarterial walls to be pushed closer together.

Referring now to FIG. 57, the pusher member 4320 may be distallyadvanced to engage the seated closure element 4500″, in thesubstantially tubular condition, during deployment. The deliveryassembly 4200, and hence the bleed back shaft 4260, are axiallymaintained in position during the deployment of the closure element4500″. Once the substantially tubular closure element 4500″ is deployed,it begins to transition from the tubular configuration to the natural,planar configuration with opposing tines 4520 and a naturalcross-section 4530 of the closure element 4500 (substantially similar tothe deployment of the closure element detailed and shown in FIGS. 51Gand 51H). Again, the opening 4610 in the blood vessel wall 4620 can bedrawn substantially closed and/or sealed via the closure element 4500″as illustrated in FIG. 51H. Subsequently, the tongs 4410 of the tissueengaging device 4400 are the retracted in the bleed back shaft 4260, andthen the bleed back shaft 4260 is retracted from the “closed” opening4610 of the puncture site.

It will again be appreciated that the bleed back shaft 4260 is composedof a material that reduces sticking of the tines 4520 of the closureelement therewith during deployment and withdrawal of the shaft from theopening, should any contact ensue. As mentioned above, beneficial shaftcompositions include any hard material that can be formed into a tubeand is also biocompatible, such as Nitinol and Stainless steel.Furthermore, the seating of the closure element 4500″ about the carrierseat 4302 is in a manner angularly off-setting the closure element tines4520 (relative to the longitudinal axis 4216) from the angular positionof the tissue engaging tongs 4410, to reduce interference duringdeployment of the closure element.

Referring now to FIG. 58, another specific embodiment of the clipapplier apparatus 4100 is illustrated that is structurally andfunctionally similar to the clip applier apparatus embodiment detailedin FIGS. 52-54. In this specific embodiment, however, the cover memberor garage tube 4330 shown in the embodiment of FIG. 52 is removed,providing a significantly reduced diametric footprint for the tube set4305 of the delivery assembly 4200. Accordingly, during advancement ofthe delivery assembly to the vessel opening 4610, via the lumen 4644 ofthe sheath 4640, protection of the seated closure element 4500″ isafforded by the sheath itself.

As above-mentioned, the diametric footprint of the clip applierapparatus 4100 in this specific embodiment is further reduced by anamount equivalent to the removal of the garage tube from the tube set4305. Hence, the tube set 4305 of the delivery assembly only includesthe pusher member 4320 of the carrier assembly 4300, and the tubularbody 4210. The tubular body 4210, which supports the carrier seat 4302,the tissue locator assembly 4202 and the tissue engaging device 4400supported within the receiving tubular body lumen 4204, may similarly becapable of axial displacement, relative to the sheath 4640, the pushermember 4320 and the closure element 4500″, in the substantially tubularconfiguration.

Furthermore, the introducer sheath 4640 will be selected to cooperatewith the tube set 4305 of the delivery assembly 4200 in a manner similarto the cooperation between the garage tube 4330 and the pusher member4302 and closure element 4500″ of the previous embodiments. That is, theinterior diameter of the sheath lumen 4644 should be sized to cooperatewith the exterior diameter of the pusher member 4320 and the seatedclosure element 4500″ to permit sliding axial displacement therebetween,yet be sufficiently snug at the distal tip to retain the closure elementin the substantially tubular configuration until it is released out ofits distal end thereof.

Referring back to FIG. 58, the tissue engaging device 4400 of thisembodiment is illustrated incorporating a similar device to thatdescribed in the embodiment of FIGS. 52-54 (i.e., centrally deployedresilient tongs 4410). It will be appreciated, however, that any tissueengaging device could be incorporated that is functionally capable ofengaging and urging the opposed arterial walls 4620′, 4620″ together andradially within the first diameter of the closure element 4500″ (aboutlongitudinal axis 4216).

Again, similar to the operation of the embodiment of FIGS. 52-54, oncethe tissue locator portion 4202 is properly oriented, the tissueengaging device 4400 can be distally deployed from a distal end of thetubular body 4210. The tissue engaging device 4400 includes one or moretongs 4410 having proximal end regions associated with a common controlshaft (not shown) operated at the handle portion of the clip applierapparatus 4100. Each resilient tong 4410 is naturally bowed in aU-shaped manner such that when continually distally advanced from thetubular body end port 4264, each tong resiliently bows radiallyoutwardly from common axis 4216, and bows upwardly toward the interiorsurface 4620 b of the opposing arterial walls 4620′, 4620″. Once thetongs 4410 of the tissue engaging device are sufficiently anchored tothe corresponding arterial walls 4620′, 4620″ (in the tissue engagingcondition similar to that shown in FIG. 52), the tubular body 4210and/or the tongs 4410 are retracted, while the pusher member 4320 andthe closure element 4500″ are substantially maintained, axially Similarto the closing condition of FIG. 53 and as shown in FIG. 58, the engagedopposing arterial walls 4620′, 4620″ are drawn and urged together,radially inward toward one another until they are disposed within thefirst diameter of the closure element 4500″. Continued retractionfurther urges the engaged opposing arterial walls 4620′, 4620″ radiallytogether under the bleed back shaft and into the channel 4540 defined bythe substantially tubular closure element 4500″.

The pusher member 4320 is then advanced distally to deploy the closureelement 4500″ off of the end of the obturator or tissue locator device4202, and out of the lumen 4644 of the introducer sheath 4640. Thedistally directed tines 4520 of the closure element 4500″ pierce theopposing arterial walls 4620′, 4620″ that are radially pulled together,via the tissue engaging device 4400 in the closing condition, within thefirst diameter. Once the substantially tubular closure element 4500″ isdeployed, it begins to transition from the tubular configuration to thenatural, planar configuration with opposing tines 4520 and a naturalcross-section 4530 of the closure element 4500 (substantially similar tothe deployment of the closure element detailed and shown in FIGS. 51Gand 51H). The arterial walls 4620′, 4620″ are thus drawn substantiallyclosed and/or sealed. Subsequently, the tongs 4410 of the tissueengaging device 4400 are retracted in the bleed back shaft 4260, and thedelivery assembly 4200 and sheath 4640 can be removed.

Generally, the present invention is directed toward a medical device andmethod for maintaining hemostasis while delivering a closure elementthrough tissue and into an opening formed in, or adjacent to, a wall ofa blood vessel or other body lumen of any size. As such, the presentinvention provides a medical device and method for use that maintains orimproves hemostasis during a medical procedure for closing and/orsealing openings through tissues and/or blood vessels. The presentinvention also includes an implantable locator that can be used tofacilitate hemostasis as well as a locator that includes hemostaticcomponents.

The apparatus can be configured to receive and retain the closureelement such that the closure element is disposed substantially withinthe apparatus. Thereby, if the apparatus is introduced via an introducersheath, for example, the closure element can be disposed within, anddelivered by way of, a lumen of the introducer sheath. The apparatusalso is configured to engage the blood vessel wall adjacent to theopening and to position the closure element substantially adjacent to anouter surface of the blood vessel wall adjacent to the opening. Theapparatus can include a locator element that locates the blood vessel toimprove placement of the closure element, where the locator canoptionally be implantable or hemostatic.

Additionally, the apparatus is configured to maintain hemostasisthroughout the medical procedure so as to inhibit blood from oozing orflowing from the blood vessel. Further, the apparatus includes anexpandable hemostatic element that expands so as to contact the bloodvessel at the opening and/or around the opening on the external surfaceof the blood vessel so as to maintain or improve hemostasis after theapparatus is retracted and the locator element is adjacent to theopening. This can include the expandable hemostatic element beingselectively expandable such that the expandable element is retractedwhile the apparatus is being placed adjacent to the opening and thelocator element is locating the blood vessel wall. The expandablehemostatic element is selectively expanded during or after the procedurefor locating the blood vessel wall so as to maintain hemostasis, andthen retracted during placement of the closure element so that theclosure element can engage tissue around the expandable element. Afterplacement of the closure element, the apparatus can be withdrawn.

When properly positioned, the apparatus can be activated to distallydeploy the closure element. During deployment, the apparatus can beconfigured to substantially uniformly expand the closure element beyonda natural cross-section of the closure element such that the closureelement, when deployed, is configured to engage a significant amount ofthe blood vessel wall and/or tissue. Engaging the blood vessel walland/or tissue, the closure element can be further configured to returnto the natural cross-section. Thereby, the engaged blood vessel walland/or tissue are drawn substantially closed and/or sealed, such that,for example, hemostasis within the opening is enhanced. Also, theimplantable locator can be held against the inner wall of the bloodvessel by the closure element, and thereby implanted, to enhancehemostasis.

During the deployment of the closure element, the expandable hemostaticelement expands at or around the opening in the blood vessel so as toprovide improved hemostasis. The expandable hemostatic element can beexpandable by various means which are described in more detail herein.In one example, the expandable hemostatic element can be selectivelyexpanded as shown herein with relation to the expandable locator, andthe expandable hemostatic element can include the features of theexpandable locator.

Since current apparatuses for sealing openings formed in blood vesselwalls can snag tissue adjacent to the openings during positioning andmay not provide an adequate seal, an apparatus that is configured toprevent inadvertent tissue contact during positioning and to engage asubstantial of amount of tissue adjacent to the opening can prove muchmore desirable and provide a basis for a wide range of medicalapplications, such as diagnostic and/or therapeutic procedures involvingblood vessels or other body lumens of any size. This result can beachieved by employing a clip applier and associated methods of use inaccordance with the present invention.

Additionally, methods of using the improved hemostasis system describedherein are shown in FIGS. 59A-59E. The methods can utilize embodimentsof the hemostasis systems as shown in the various figures. As such, theuse of a hemostasis member during the process of delivering a closureelement to close an opening in a body lumen can be used as shown, andcan have many identical or similar structures that perform identical orsimilar functions to the embodiments of the invention described hereinin reference to the figures. Accordingly, the description below shouldbe considered in view of the descriptions herein of the differentembodiments of hemostasis systems and methods of using the same.Furthermore, those of ordinary skill in the art will appreciate that oneor more of the uses, components, and/or features of the embodiment shownin FIGS. 59A-59E may also be incorporated in the other embodimentsdescribed herein, and vice versa.

Referring now to FIGS. 59A-59E, methods of using a hemostasis system52201 will be described. The hemostasis system 52201 can be used withclosure element applying devices described herein, and may includevarious features of such closure element applying devices as describedherein. However, FIGS. 59A-59E only show the hemostasis system 52201 forpurposes of clarity, and it should be understood that the hemostasissystem 52201 is employed so as to provide improved hemostasis during theprocess of applying a closure element to seal a blood vessel 52600.

Referring now to FIG. 59A, there is shown a vessel 525600 having anexternal surface 52620 a and an internal surface 52620 b. The vessel52620 includes an opening 52610 disposed therein where a medical device,such as a catheter, can be inserted for performing a medical procedure.As described above, a guidewire (not shown) can be inserted through theopening 52610 of the vessel 52620 such that the hemostasis system 52201can be inserted into the opening 52610 by being traversed over theguidewire.

The hemostasis system 52201 is illustrated to include a sheath 52640through which the components of the locator assembly, hemostasiscomponents, and tube set, described herein, can be deployed into and/oradjacent to the opening 52610 in the vessel 52620. As illustrated inFIG. 59A, the sheath 52640 is disposed through the opening 52610 suchthat locator 52200 extends therefrom and into the vessel 52620. Thehemostasis tube 52212 is also shown to extend from the sheath 52640 soas to form a gap 52213 between the sheath 52640 and the locator 52200. Awire 52211, or other suitable mechanism for operation of the locator52200 and/or hemostasis system 52201 is disposed within a lumen in thehemostasis system 52201, such as within the hemostasis tube 52212.

As shown in FIG. 59B, when the locator 52200 is withdrawn so as tolocate the vessel 52620 by contacting the internal surface 52620 b ofthe vessel, the gap 52213 is positioned at the opening 52610 of thevessel 52620. This provides incomplete hemostasis because blood is ableto ooze, seep, and/or flow through the opening 52610 at the gap 52213.As such, the process of locating the vessel 52620 can cause incompletehemostasis, which is undesirable.

As shown in FIG. 59C, the hemostasis system 52201 can be manipulated sothat an expandable member 52203 can be expanded so as to fill the gap52213 and plug the opening 52610 in the vessel 52620. For example, thewire 52211 can be manipulated in a manner that causes the expandablemember 52203 to begin to expand so as to fill the gap 52213 and plug theopening 52610 of the vessel 52620. In another example, the firstmanipulation of the wire 52211 can expand the locator 52200, and thesecond manipulation of the wire 52211 can expand the expandable member52203. The order of which expandable members 52203 and/or the locator52200 expand may be selected depending on the characteristics ofimproved hemostasis.

As shown in FIG. 59D, the fully expanded expandable member 52203 has asufficient size to plug the opening 52610 in the vessel 52620. Also, theexpanded expandable member 52203 provides hemostasis so that blood isinhibited from passing through the opening 52610. The expandedexpandable member 52203 can extend from the locator 52200 to the sheath52640 or any distance therebetween. The hemostasis can be maintainedthroughout the process of delivering the closure element into the vessel52620 so as to close the opening 52610.

While not shown, the expandable member 52203 and locator 52200 can becollapsed as the closure element is deployed into the vessel 52620. Thecollapse of the expandable member 52203 and locator 52200 can befacilitated as described herein. For example, the wire 52211 can bemanipulated in a manner that automatically causes the collapse as theclosure element is delivered into the vessel 52620. Otherwise, themechanism described herein that collapses the locator and hemostaticmember as the closure element is deployed can be used.

FIG. 59E shows the hemostasis system 52201 can include an expandablemember 52203 that expands radially or laterally in a more disc-likeconfiguration so that it can contact the outer wall 52620 a of thevessel 52620 and form a seal to inhibit bleeding. An expandablehemostasis member 52203 can be configured as a cap and/or plug for thehole 52610 and may have an expanded outer diameter that is larger thanthe diameter of the hole 52610.

Generally, closure systems that are configured to close openings in bodyvessels can suffer from incomplete hemostasis during the closingprocedure. Such incomplete hemostasis allows blood or other body fluidsto seep into the medical devices and increase the difficulty in closingand sealing the opening. For example, in an embodiment of a currentclosure system, the nylon shaft of the locator system is smaller thanthe arteriotomy or sheath. As the sheath is retracted during thepositioning of the locator or split during the advancement of the tubeset, blood can ooze out of the opening before the closure element isapplied to close the opening. In order to inhibit the oozing of bloodthrough the opening, the hemostasis system of the present invention canbe applied to inhibit such oozing and provide improved hemostasis.

In one embodiment, the hemostasis is accomplished by the distal tip ofthe shaft of the locator selectively expanding. For example, the shaftcan be a nylon shaft that is tensioned so as to longitudinally shortenand laterally buckle and expand at the distal end. Such buckling expandsthe nylon shaft laterally so as to plug or cap the opening in thevessel. Additionally, other embodiments of hemostasis systems can beapplied as described herein.

A hemostasis system in accordance with the present invention isconfigured to substantially plug or cap an opening in a vessel so as toprovide improved hemostasis during the deployment of a closure elementinto the vessel so as to close and seal the opening. Such a hemostasissystem can be present in various configurations that have an expandablemember that expands so as to plug the opening. Expandable members arewell known in the art and can be expanded by a number of mechanisms.

The expandable members of the present invention can be self-expandableso as to automatically expand when subjected to a particular stimulus.Such self-expandable members can include shape-memory materials (e.g.,shape memory alloys and shape memory polymers) that expand as is wellknown in the art. For example, shape memory alloys automatically expandwhen heated to a certain temperature by the body. Shape memory alloys,such as nitinol, are also known as superelastic metals.

Additionally, a self-expandable member can have an expandedconfiguration and a contracted configuration, where the member isretained within a device (e.g., sheath) in the contracted configurationand automatically expands when removed from the device. For example, theself-expandable member can have a contracted configuration that fits andis held therein by a sheath as described herein, and automaticallyexpands to the expanded configuration when the sheath is retracted overthe expandable member.

In one embodiment, the expandable member is fluid absorbable such thatthe fluid that oozes through the opening induces the expandable memberto expand. An example of this can be a hydroscopic polymer (e.g.,hydrogel) that swells and absorbs the body fluid.

In one embodiment, the expandable member is expanded when a mechanism isactuated so as to induce the expansion. This can be similar to aballoon, such as a balloon in a balloon-expandable stent, or aninflatable bladder. The mechanism can be a hydraulic or fluidicmechanism with tubes and pumps that can be automatic and/or selectivelycontrolled.

In one embodiment, the mechanism can be a wire or shaft that changes theconfiguration of the expandable member from unexpanded to expanded andback to being unexpanded, as desired. Such an expandable member can haveexpandable elements and components similar to the locator assembly asdescribed herein. This can include the expandable member expanding viathe same mechanism that expands the locator assembly or a similarlyconfigured mechanism.

FIGS. 60A-60B are a schematic representation that shows expansion of anexpandable hemostasis system 53000, where FIG. 60A shows the hemostasissystem 53000 in the unexpanded state and FIG. 60B shows the expandedstate. The hemostasis system 53000 includes a hemostasis member 53002having an internal lumen 53008 that extends from a proximal end 53004 toa distal end 53006. The hemostasis member 53002 is divided into anon-expandable member 53002 a at the proximal end 53004 and anexpandable member 53002 b at the distal end 53006. The non-expandablemember 53002 a and expandable member 53002 b can be two separatematerials joined together, or they can be a unitary material with aportion that selectively expands (e.g., expandable member 53002 b). Thehemostasis member 53002 can be any length 53010, which can be divided inany manner to provide an appropriate non-expandable member 53002 alength 53012 a and an appropriate expandable member 53002 b length 53016a while in the non-expanded state. Also, the non-expandable member 53002a can have a non-expandable diameter 53014 a, and the expandablediameter 53018 a that is sufficient for providing hemostasis andplugging or capping the opening in the body lumen. After the hemostasissystem 53000 is expanded as shown in FIG. 60B, the expandable member53002 b expands to a larger diameter 53018 b. Such an expansion indiameter can result in longitudinal shorting in length 53016 b.

FIGS. 61A-61F are schematic illustrations of various other embodimentsof hemostasis systems. FIG. 61A shows an embodiment of a hemostasissystem 53020 in a non-expanded state that includes a hemostasis member53022 that has a non-expanding member 53022A and an expanding member53022B. Also, the hemostasis system 53020 includes a wire 53026 that iscoupled to a rigid base 53024 such that a proximally oriented forceapplied to the wire 53026 can pull the rigid base 53024 so as to buckleand/or otherwise expand the expanding member 53022B relative to thenon-expanding member. Alternatively, the wire 53026 can be configured asa tube, shaft, pin, combinations thereof, or the like that can provide asimilar function in expanding the expanding member 53022B. As such, thewire 53026 can have sufficient tensile strength so as to impart a forceto the expanding member 53022B so as to induce expansion thereof oractivate a mechanism that expands the expanding member 53022B. Thenon-expanding member 53022A may be a separate material from theexpanding member 53022B or a unitary material therewith. Thenon-expandable member 53022A may similarly expand if desired. However,an external structural member, such as a sheath or tube, can be used tohold the non-expanding member 53022A in place and restrict lateralexpansion.

FIG. 61B shows an embodiment of a hemostasis system 53030 having asubstantially tubular non-expanding member 53032 and an expanding member53034 that expands to a substantially conical shape. The tubularnon-expanding member 53032 may be capable of expanding; however, it isshown in the non-expanded state so as to be differentiated from theexpanding member 53034 that expands within the opening of the vessel soas to form a plug. Also, the taper of the expanding member 53034 can bereversed with the larger end being coupled with the non-expanding member53032. Insertion of the expanding member 53034 with the smaller endbeing inserted into a blood vessel can provide a plug/cap with afriction fit.

FIG. 61C shows an embodiment of a hemostasis system 53040 having asubstantially tubular non-expanding member 53042 and an expanding member53044 that buckles laterally so as to expand in diameter and shorten inlength. The buckling can cause the lateral diameter to vary along thelength with wide portions being of sufficient diameter to function as aplug in the opening and provide improved hemostasis. The buckling canalso contour with the shape of the blood vessel opening and/or expandgreater at the proximal end.

FIG. 61D shows an embodiment of a hemostasis system 53050 having asubstantially tubular non-expanding member 53052 and an expanding member53054 that expands or bows outwardly in the lateral direction. Thebowing outwardly can cause the lateral diameter to change or curve alongthe length with wide portion being of sufficient diameter to function asa plug in the opening and provide improved hemostasis. Usually, thebowing is caused by the material curving outwardly, laterally ratherthan the material buckling. Alternatively, the bowing can also besimilar to the inflation of a balloon or bladder.

FIG. 61E shows an embodiment of a hemostasis system 53050 a having asubstantially tubular non-expanding member 53052 a and an expandingmember 53054 a that expands or widens outwardly in the lateral directionto form a plate or discus like shape. The outward expansion can causethe lateral diameter to change to a sufficient diameter to function as aplug, cap, lid or other covering that provides hemostasis to theopening. Usually, the widening is caused by the material expandingoutwardly, laterally rather than the material buckling. Alternatively,the widening can also be similar to the inflation of a balloon orbladder.

FIG. 61F shows an embodiment of a hemostasis system 53050 b having asubstantially tubular non-expanding member 53052 b and an expandingmember 53054 b that expands or widens outwardly in the lateral directionto form a cupped, suction cup, or Frisbee like shape. The outwardexpansion can cause the lateral diameter to change to a sufficientdiameter to function as a plug, cap, lid or other covering that provideshemostasis to the opening. Usually, the widening is caused by thematerial expanding outwardly, laterally rather than the materialbuckling. Alternatively, the widening can also be similar to theinflation of a balloon or bladder. Additionally, the distal or vesselside of the expanding member 53054 b can include a plug 53055 thatinserts into and plugs the vessel hole.

FIGS. 62A-62B illustrate an embodiment of a removable anchor system54000. The removable anchor system 54000 can include a sheath 54640 thatcan be configured as any sheath or outer cover or outer tube asdescribed herein. An anchor sheath 54002 can include a pusher member54004, a removable anchor 54006, and the first anchor wire portion 54008and second anchor wire portion 54010 positioned opposite of the firstanchor wire. The first and second anchor wire portions 54008, 54010 aswell as additional anchor wires can have equal or even spacing as wellas unequal or uneven spacing with around the lumen 54003 of the anchorsheath 54002. The first anchor wire 54008 and second wire controller54010 can be formed from the same wire. As such, the same wire forms thefirst and second anchor wire portions 54008, 54010 and the removableanchor 54006.

The first and second anchor wire portions 54008, 54010 (e.g., of thesame wire) can traverse the lumen 54003 until reaching a first wirecontroller 54014 that couples with and controls the first anchor wireportion 54008 and a second wire controller 54018 that couples with andcontrols the second anchor wire portion 54010. The first wire controller54014 can include a first mechanism 54016 that can automatically and/orselectively be pulled to control the distal end of the first anchor wireportion 54008. A similar second mechanism 54020 can control the secondwire controller 54018 and second anchor wire portion 54010.

Also, the pusher member 54004 can be operably coupled with a push membercontroller 4019 for selective axial motion or selective positionsetting.

Additionally, multiple wires can be used to form additional anchorssimilarly as formed from the first anchor wire portion 54008, secondanchor wire portion 54010, and the anchor 54006. As such, while FIG. 63shows a two lobe anchor formed from a single wire, multiple wires can beused to form multiple two lobe anchors. Alternatively, a single wire canform multiple-lobed clover shaped anchors that are all controlled byfirst and second anchor wire portions operated by the wire controllers.

FIG. 63 shows the removable anchor system 54000 after the removablelocator 54006 at the distal end has been expanded within a blood vessel5620. In order to expand, the pusher member 54004 can be held oradvanced distally compared to the relative proximal motion of the anchorsheath 54002, which is indicated by the arrows. The locator 54006automatically expands when passed out of the anchor sheath 54002. Thefirst and second anchor wires 54008, 54010 are shown to be pulledproximally so that the locator 54006 pushes up against the inside of theblood vessel 5620. FIG. 63 also shows a hemostasis tube 54030 and anexpandable hemostasis member 53034 that can expand outwardly to providehemostasis.

The first and second mechanisms 54018, 54020 at the proximal end of theremovable anchor system 54000 can be activated to selectively pull thefirst and second anchor wire portions 54008, 54010. This can includeselectively pulling both the first and second anchor wire portions54008, 54010 so that the locator 54006 is brought tight against theblood vessel 5620.

FIGS. 64A-64B show an anchor being collapsed and withdrawn. As such, thefirst anchor wire portion 54008 can be pulled while the second anchorwire portion 54010 is not pulled (e.g., stop) so that locator 54006begins to collapse and be pulled proximally as shown in FIG. 64A. FIG.64B shows the removable locator 54006 can be deformed and pulledproximally out of the blood vessel 5620 by pulling one or more of thefirst and second anchor wire portions 54008, 54010. The removal of theremoval locator 54006 can occur before or as a closure element isdeployed to seal the opening 5610 of the vessel 5620.

FIGS. 65A-65C show an implantable, removable anchor system 54000 beingused with a carrier assembly 54300 and tube set 54305 that deploys ablood vessel closure element 4500 into a vessel 5620. The anchor system54000, carrier assembly 54300 and tube set 54305 can be configured asdescribed herein.

FIG. 65A shows the anchor system 54000 being located within an opening5610 of the vessel 5620. The locator 54006 is positioned against theinternal surface of the vessel 5620 by pulling on the first anchor wireportion 54030 and second anchor wire portion 54032 at the same time todraw the locator 54006 against the vessel 5620 so as to provide thelocation of the vessel 5620. The anchor 52006 can be opened within ablood vessel 5620 as shown in the figures, and can be held byselectively pulling the first anchor wire portion 54030 and the secondanchor wire portion 54032. These anchor wire portions 54030, 54032 areconfigured to be cut, decoupled, degraded, dissolved, or otherwisedecoupled from the locator 54006. This allows for the anchor 54006 to beimplanted. Optionally, the anchor 54006 can be formed of an implantablemetal or plastic as well as a degradable material, such as a degradablepolymer. The anchor wire portions 54030, 54032 can be prepared ofmaterials common to suture materials as well as biocompatible polymersthat are biodegradable or biostable.

FIG. 65B shows the carrier assembly 54300 and tube set 54305 beinglocated adjacent to the opening 5610 in the vessel 5620, and can bepositioned as described herein. As shown, the closure element 4500penetrates through the vessel 5620 at a diameter wider or circumferencelarger than the locator 54006 after being deployed by the tube set 54305and carrier assembly 54300. The closure element 4500 can be insertedinto the blood vessel 5620 before, during or after the expandablehemostasis member 52213 is retracted or unexpanded as shown by thedashed lines. Accordingly, the dashed lines show the hemostasis member52213 in the deployed and expanded orientation. The hemostasis member52213 can be collapsed upon deployment of the closure element 4500.

FIG. 65C shows the closure element 4500 collapsed and returned to itsnatural and substantially planar shape. While the closure element 4500is collapsing, it grabs the implantable anchor 54006 and draws itagainst the blood vessel 5620 to close the opening 5610. The anchor54006 is decoupled from the first and second anchor wires 54030, 54032.

Optionally, the closure element and/or anchor 54006 can include portionsthat are hemostatic, such as having a hemostatic agent coated onselected surfaces, such as non-blood flow facing surfaces or tissuefacing surfaces.

FIGS. 66A-66B show another embodiment of an anchor 54006 a, which can beremovable or implantable, in the form of a tight coil. The coiled anchor54006 a can function much as the looped anchor 54006 of FIGS. 62-66.FIG. 67A shows that the closure element 4500 can reach around the edgesof the coiled anchor 54006 a so that it is pulled against the vessel.FIG. 66B also shows the first and second anchor wires 54030 a, 54032 athat are dissolvable.

FIG. 67A shows an anchor 54050 that is integrally formed with or coupledto one or more anchor wire portions 54040 via a coupler 54020. Thecoupler 54020 can be selectively undone or dissolved to decouple animplantable anchor 54050 from the anchor wire portion 54040.Alternatively, the coupler 54020 can couple to different materials of aremovable anchor 54050 and the anchor wire portion 54040. The shape ofthe anchor 54050 is a spiral, and which can be delivered into a vesseland expanded as described herein. The spiral anchor 54050 can also beextracted from the blood vessel by pulling on the anchor wire 54040 sothat the anchor 54050 unwinds into a lumen 54042 of a locator assembly54044.

FIG. 67B shows an anchor 54052 and anchor wire portion 54040 and coupler54020 substantially as FIG. 67A. However, the anchor 54052 has acontinuous looped shape with one or more loops (shown with 2 loops). Thelooped anchor 54052 can be deployed and withdrawn or implanted asdescribed herein.

FIGS. 68A-68B show an anchor system 54000 that is operated with anexpandable hemostasis member 52213. The expandable hemostasis member52213 and anchor system 54000 (removable or implantable) can be deployedand expanded as described herein. As shown, the expandable hemostasismember 52213 expands and causes the first and second anchor wireportions 54008, 54010 to be tightened and drawn against the vessel 5620so that the anchor 54006 locates and anchors against the inside of thevessel 5620 while the expandable hemostasis member 52213 is pushedagainst the outside of the vessel 5620 to provide hemostasis.

FIG. 68A shows a dashed line 54025 marking the outer diameter of theexpandable hemostasis member 52213. As such, the closure element (notshown) can have a diameter larger than 54025 when deployed with thehemostasis member 52213 after being expanded. Accordingly, dashed line54025 shows the diameter of closure element when deployed around anexpanded hemostasis member 52213. The closure element can then piercethe blood vessel outside or wider than the dashed line 54025. This canensure the expandable hemostasis member 52213 can be unexpanded andwithdrawn. As shown, the diameter of dashed line 54025 is also widerthan the diameter of the anchor 54006 so that the closure element wrapsaround and encompasses the anchor 54006 upon deployment andimplantation.

FIG. 68B shows an instance where the expandable hemostasis member 52213is unexpanded before or as the closure element pierces the vessel to anunexpanded outer diameter 54026 shown by the dashed line. The dashedline 54026 shows a diameter larger than the diameter of the unexpandedhemostasis member 52213, and the closure element can have a diameterthat is larger than the dashed line 54026. As such, the closure element(not shown) can have a diameter upon deployment that is larger than thediameter of the unexpanded diameter 54026 of the hemostasis member52213. The closure element can also have a diameter that is smaller thanthe expanded diameter 54025 of the expanded hemostasis member 52213and/or anchor 54006.

The anchors described herein can function as locators and can beconfigured with components described herein in connection to locatorsand locator assemblies. Also, the anchors can be prepared fromshape-memory materials that are alloys or polymers, as well as metals orpolymers that are implantable as well as degradable. Examples of theclosure element materials can be used as the anchor materials.

The embodiments of hemostasis systems and the components for providingimproved hemostasis described herein are representative of the differenttypes of hemostasis providing elements that can be included in a deviceand/or system for delivering a closure element into a vessel for closingand sealing an opening therein. The hemostasis elements can be variedfrom that which has been illustrated and described; however, thefunction remains to provide improved hemostasis during the closureelement delivery process. As such, the skilled artisan could makevarious modifications to the hemostasis elements and still provideimproved hemostasis. Accordingly, some of the variations that may beemployed will be discussed in more detail below.

The hemostasis system has been illustrated and described as havingnon-expanding portions and expanding portions. This can include a singlematerial with portions configured to function different in thenon-expanding portion compared to the expanding portion. For example,the material at the expanding portion can be narrower or less resistantto forces so as to preferentially expand compared to the non-expandingportion. The non-expanding portion could also have a non-expanding shapeor solid composition without an internal lumen, such as a rod, shaft,wire, pin, and the like. Alternatively, the non-expanding portion can beconfigured identically with the expanding portion, and the hemostasissystem includes a member that confines the non-expanding portion so asto inhibit expansion. For example, the sheath can be retracted enough toonly expose the expanding portion, and thereby allow the expandingportion to expand while retaining the non-expanding portion within thesheath such that contact between the sheath and the non-expandingportion inhibits expansion. A similar configuration can be applied withdifferent materials for the non-expanding portion and the expandingportion, where the material of the non-expanding portion is coupled tothe material of the expanding portion. Additionally, the non-expandingportion can have a material or plurality of materials that are differentfrom the material or plurality of materials of the expanding portion.For example, the non-expanding portion can have a structurallyreinforcing member, such as rod, ribs, braces, or the like that inhibitexpansion. On the other hand, the expandable portion can have expandablemembers (e.g., shape memory materials) disposed in a polymeric memberthat is capable of expanding, whereby the expandable members cause thepolymeric member to correspondingly expand.

In the instance the non-expanding portion and the expanding portion aredifferent materials coupled together, such coupling can be accomplishedby well known methods for attaching a material to another material. Thetype of coupling employed can depend on the type of the first materialand the second material. For example, the coupling can be achieved byadhesive, melt-bonding, sintering, welding, brazing, threading, frictionresistance, and the like.

In one example, the expandable member can include a laminate structurehaving structural elements that can be expanded, and thereby expand thelaminate structure. The structural elements that can expand can beconfigured similarly to a stent that expands when deployed. Thus, thehemostasis system can include the components of a stent delivery systemthat are used to expand a stent, which can include self-expandingsystems, balloon/bladder expanding systems, and the like.

The materials of the hemostasis system can be varied and still retainthe same function. Generally, the hemostasis materials are biocompatibleso that adverse physiological reactions do not occur when the expandablemember expands to contact and plug the opening in the vessel. Suchbiocompatible materials can include metals, alloys, superelastic alloys(e.g., shape memory alloys) polymers, plastics, foams, elastomers,natural or synthetic rubbers, ceramics, and combinations thereof.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

We claim:
 1. A vessel closure device delivery system, comprising: adelivery device that couples to a vessel closure clip for delivering theclip onto a blood vessel; a retractable vessel locator removeablyattached to the delivery device, a distal end of the vessel locatoradapted to transition from a collapsed state suitable for insertion intoa vessel and an expanded state that lodges against a wall of the vesselfrom inside the vessel; and a vessel closure clip.
 2. A system as inclaim 1, wherein the delivery device comprises a clip carrier assembly,the clip carrier assembly comprising an elongated member retainingvessel closure clip in a deliverable configuration, a pusher memberadapted to deploy the vessel closure clip, and an actuator to actuatethe pusher member with respect to the elongated member to deploy theclip.
 3. A system as in claim 2, wherein the carrier assembly furthercomprises a cover member for retaining vessel closure clip on theelongated member during delivery, the cover member coupled to anactuator to release the clip during deployment.
 4. A system as in claim1, wherein the vessel locator is part of a locating device sized andconstructed to function as a guidewire in the collapsed state, andwherein the locating device may be used to guide the delivery device tothe vessel wall.
 5. A system as in claim 4, wherein the delivery devicemay be removed from the locating device so that the locating device canbe used to deliver a procedural sheath.